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https://www.fda.gov/Drugs/InformationOnDrugs/ucm113978.htm

May 7, 2019: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement

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Center Date Time Location
CDER May 7, 2019 9:00 a.m. to 4:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland

Agenda

The committee will discuss the following topics: (1) approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of ‘exposure-matching’ under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of ‘exposure matching,’ including the necessary assumptions and any limitations.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2019 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-1043. The docket will close on May 6, 2019. Submit either electronic or written comments on this public meeting by May 6, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 19, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before April 29, 2019 will be provided to the committee. Comments received after that date but by May 6, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-1043 for “Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions–To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 22, 2019.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 23, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 7, 2019 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • FDA Advisory Committee Information Line 1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm635685.htm

Pulmonary-Allergy Drugs Advisory Committee Roster

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David J. Lederer, MD, MS
Expertise: Pulmonary and Interstitial Lung Disease
Epidemiology
Term: 12/21/2017 – 5/31/2021
Associate Professor of Medicine and Epidemiology
Division of Pulmonary, Allergy and Critical Care Medicine
Columbia University Medical Center
161 Fort Washington Ave, Rm 3-321A
New York, New York 10032

Gailen D. Marshall Jr., MD, PhD, FACP
Expertise: Allergy and Immunology
Term: 6/1/2018 – 5/31/2022
The R. Faser Triplett Sr MD Chair of Allergy and Immunology
Medical Director, UMMC Clinical Research Support Program/Clinical Research and Trials Units
Professor of Medicine, Pediatrics and Pathology
Vice Chair for Research, Department of Medicine
Director, Division of Clinical Immunology and Allergy
Chief, Laboratory of Behavioral Immunology Research
The University of Mississippi Medical Center
2500 North State Street N416
Jackson, Mississippi 39216

https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm107568.htm

April 26, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER April 26, 2019  8:30 a.m. to 1:00 p.m.
 
Tommy Douglas Conference Center
10000 New Hampshire Ave.
Silver Spring, MD 20903

Agenda

The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee).

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0795. The docket will close on April 25, 2019. Submit either electronic or written comments on this public meeting by April 25, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 25, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before April 11, 2019, will be provided to the committee. Comments received after that date but by April 25, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-0795 for “Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions–To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 3, 2019.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 4, 2019.

Webcast Information

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the April 26, 2019 Antimicrobial Drugs Advisory Committee meeting.

Contact Information

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Kalyani Bhatt (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm634408.htm

April 25, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER April 25, 2019  8:30 a.m. to 4:30 p.m.
 
Tommy Douglas Conference Center
10000 New Hampshire Ave.
Silver Spring, MD 20903

Agenda

The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee).

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0747. The docket will close on April 24, 2019. Submit either electronic or written comments on this public meeting by April 24, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 24, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before April 11, 2019, will be provided to the committee. Comments received after that date but by April 24, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-0747 for “Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions–To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 3, 2019.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 4, 2019.

Webcast Information

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center. Therefore, CDER will not be providing a webcast of the April 25, 2019 Antimicrobial Drugs Advisory Committee meeting.

Contact Information

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Kalyani Bhatt (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm634398.htm

May 8, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER May 8, 2019 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland 20993

Agenda

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2019 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0983. The docket will close on May 7, 2019. Submit either electronic or written comments on this public meeting by May 7, 2019. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 7, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before April 24, 2019 will be provided to the committee. Comments received after that date but by May 7, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-0218 for “Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions–To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 16, 2019.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 17, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the May 8, 2019 meeting of the Pulmonary-Allergy Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: https://www.fda.gov/AdvisoryCommittees/default.htm.

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Cindy Chee (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm634382.htm

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

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Drug Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abacavir and Lamivudine – Epzicom ViiV Healthcare Company Medical (PDF – 2.8 MB) Clinical pharmacology (PDF – 158 KB) Statistical (PDF – 693 KB) PREA Abacavir, Dolutegravir, and Lamivudine – Triumeq ViiV Healthcare Company Medical (PDF – 443 KB) Clinical pharmacology (PDF – 128 KB) None PREA Abacavir sulfate – Ziagen ViiV Healthcare Company Medical (PDF – 4.2 M B) Clinical pharmacology (PDF – 3 MB) Statistical (PDF – 4.7 MB) PREA Abatacept – Orencia Bristol-Myers Squibb Company

Medical (PDF – 259 KB)

Medical Addendum (PDF – 469 KB)

Clinical pharmacology (PDF – 2.3 MB)

Clinical pharmacology (PDF – 269 KB)

None BPCA AbobotulinumtoxinA – Dysport Ipsen Bipharm Limited CDTL Review (PDF – 2 MB)

Medical (PDF – 3 MB)

None Statistical (PDF -2 MB) PREA Acetaminophen – Ofirmev MallInc.krodt, Inc. Medical (PDF – 1.3 MB) Clinical pharmacology (PDF – 5.4 MB) Statistical (PDF -378 KB) PREA Acyclovir 5%, hydrocortisone 1% – Xerese Valeant International Bermuda Medical (PDF -885 KB) None None PREA Adalimumab-atto – Amjevita Amgen Inc.

CDTL Review (PDF – 4.3 MB)

Medical (PDF – 199K B)

Medical (PDF – 336KB)

DD Summary Review (PDF – 2.9 MB)
 

Clinical pharmacology (PDF – 3 MB) Statistical (PDF – 416 KB)

Statistical  (PDF – 363 KB)

Statistical (PDF – 717 KB)

 PREA Adalimumab – Humira AbbVie Inc. Medical (PDF – 527 KB) None None PREA Adapalene and benzoyl peroxide – Epiduo Galderma Laboratories, LP Medical (PDF – 2.2 MB) Clinical pharmacology (PDF -124 KB) Statistical (PDF -577 KB) PREA Adapalene and benzoyl peroxide – Epiduo Forte Galderma Research and Development LLC Medical (PDF – 6.2 MB) Clinical pharmacology (PDF -3.6 MB) Statistical (PDF -1.6 MB) PREA Albuterol sulfate – ProAir RespiClick Teva Pharmaceutical Products R. & D., Inc. Medical (PDF – 3 MB) Clinical pharmacology (PDF -4 MB) Statistical (PDF -2.2 MB) PREA Albuterol sulfate – ProAir RespiClick  Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF – 859 KB) Clinical pharmacology (PDF -2.5 MB) Statistical (PDF -1.1 MB) PREA Aliskiren – Tekturna Noden Pharma DAC CDTL (PDF –  310 KB) Clinical pharmacology (PDF -3.3 MB) Statistical (PDF – 442 KB) BPCA Amphetamine – Adzenys ER Neos Therapeutics, Inc. Medical (PDF – 1.9 MB) Clinical pharmacology (PDF – 4.1 KB) None PREA Amphetamine Extended-Release Orally Disintegrating Tablets – Adzenys XR-ODT  Neos Therapeutics, Inc. Medical (PDF – 470 KB) Clinical pharmacology (PDF -3.3 MB) None PREA Amphetamine – Dyanavel XR Tris Pharma Medical (PDF – 1.8 MB) Clinical pharmacology (PDF -4.8 MB) Statistical (PDF -767 KB) PREA Aprepitant – Emend Merck Sharp & Dohme Corp. Medical (PDF – 5.7 MB)

Medical Addendum (PDF -1.1 MB)

Medical DD memo (PDF -2.9 MB)

Clinical pharmacology (PDF -5  MB)

Clinical pharmacology addendum (PDF -424 KB)

Statistical (PDF -1.4 MB) PREA Aprepitant – Emend Merck Sharp & Dohme Corp. Medical (PDF – 553KB) Clinical pharmacology (PDF -5MB)

Addendum (PDF -105KB)

Statistical (PDF -1.2MB) PREA Aripiprazole – Abilify Otsuka Medical (PDF – 2.4MB) None Statistical (PDF -409KB) PREA Asenapine – Saphris Forest Laboratories, Inc. Medical (PDF – 5.4MB)

Medical (PDF – 4MB)

Clinical pharmacology (PDF -3.8MB) Statistical (PDF -3MB) BPCA Atazanavir – Reyataz Bristol-Myers Squibb Company Medical (PDF – 14.1MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -1.9MB) BOTH Atazanavir – Reyataz  Bristol-Myers Squibb Company Medical (PDF – 1.6MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -3.9MB) BOTH Atazanavir – Reyataz  Bristol-Myers Squibb Company Medical (PDF – 461 KB) Clinical pharmacology (PDF – 318 KB) Statistical (PDF – 682 KB) BOTH

Atropine-pralidoxime – DueDote

Meridian Medical Technologies, Inc.

CDTL (PDF – 402 KB)

Medical (PDF – 886 KB)

Clinical pharmacology (PDF –  1 MB) None PREA Atropine Sulfate – Isopto Atropine 1% Alcon Research, Ltd. Medical (PDF – 663KB) Clinical pharmacology (PDF – 480KB) Statistical (PDF – 230KB) PREA Atropine Sulfate Ophthalmic Solution Akorn, Inc. Medical (PDF – 1.2 MB) Clinical pharmacology (PDF – 1MB) Statistical (PDF – 287KB) PREA Azelastine hydrochloride – Astepro Meda Pharmaceuticals Clinical (PDF -1 .4MB) None Statistical (PDF -473 KB PREA Azelastine hydrochloride – Astepro Meda Pharmaceuticals Inc. Medical (PDF – 2MB) None None PREA Azelastine hydrochloride and Fluticasone propionate – Dymista Meda Pharmaceuticals, Inc. Medical (PDF – 2.9MB) None Statistical (PDF -2.1MB) BPCA Baloxavir marboxil – Xofluza NEW Shionogi, Incorporated

CDTL (PDF – 869 KB)

Medical (PDF – 414 KB)

Clinical pharmacology (PDF –  3 MB) Statistical (PDF –  2 MB) PREA Barium sulfate – E-Z-HD  Bracco Diagnostics Inc. Medical (PDF – 2.4MB) Clinical pharmacology (PDF -642KB) Statistical (PDF -988KB) PREA Barium sulfate – READI-CAT 2 & READI-CAT 2 SMOOTHIE  Bracco Diagnostics Medical (PDF – 2.4MB) Clinical pharmacology (PDF -702KB) Statistical (PDF -1.2MB) PREA Barium sulfate  – Varibar Pudding Bracco Diagnostics, Inc. Medical (PDF – 1MB) None None  PREA Barium sulfate – Liquid E-Z-Paque Bracco Diagnostics, Inc. DD Summary Review (PDF – 233 KB) None None PREA Beclomethasone dipropionate – Qnasl Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF – 3.7MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -959KB) PREA Benralizumab – Fasenra AstraZeneca AB Medical (PDF – 1.7 MB) Clinical pharmacology (PDF -7 MB) Statistical (PDF – 2 MB) PREA Bimatoprost ophthalmic solution, 0.03% – Latisse Allergan, Inc. DD Summary Review (PDF – 966KB)

CDTL Review (PDF – 3.4MB)

Medical (PDF – 1.6MB)

None Statistical (PDF -946KB)

Statistical Addendum (PDF – 127KB)

PREA Blinatumomab – Blincyto  Amgen, Inc. Medical (PDF – 9 MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -374KB) BPCA Bortezomib – Velcade Millennium Pharmaceuticals, Inc. Medical (PDF – 3.5MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -374KB) BPCA Budesonide – Entocort EC Elan Pharma International Medical (PDF – 2.9MB) Clinical pharmacology (PDF -2.8MB) Clinical pharmacology (PDF -2.8MB) PREA Brimonidine tartrate – Lumify Bausch + Lomb CDTL Review (PDF – 2.5 MB)

Medical (PDF – 556 KB)

Clinical pharmacology (PDF –  51 KB) Statistical (PDF – 219 KB) PREA Brivaracetam- Briviact  UCB, Inc.

CDTL Review (PDF – 297 KB)

Medical (PDF – 1 MB)

Clinical pharmacology (PDF –  2 MB) None

PREA

Budesonide/formoterol fumarate dehydrate –  Symbicort AstraZeneca Pharmaceuticals, LP Medical (PDF – 3.4 MB) Clinical pharmacology (PDF – 1.2 MB) Statistical (PDF – 2.5 MB) BOTH Buprenorphine – Butrans Purdue Pharma L.P. Medical (PDF – 4.1 MB) Clinical pharmacology (PDF – 1.5 MB) None PREA Cabazitaxel – Jevtana Sanofi-Aventis U.S., L.L.C. Medical (PDF – 1.5 MB) Clinical pharmacology (PDF – 1.2 MB) None BPCA Calcipotriene and Betamethasone dipropionate – Taclonex LEO Pharma A/S Medical (PDF -5.6MB) Clinical pharmacology (PDF -2.4MB) Statistical (PDF -564KB) PREA Calcipotriene and Betamethasone dipropionate – Taclonex LEO Pharma A/S c/o LEO Pharma, Inc. Medical (PDF – 3.7MB) Clinical pharmacology (PDF -2.7MB) None PREA Calcium Gluconate injection – Calcium Gluconate injection Fresenius Kabi USA, LLC

Medical (PDF – 4 MB)

Medical CTDL (PDF – 1.5 MB)

Clinical pharmacology (PDF – 1 MB) None PREA Capecitabine – Xeloda Hoffmann-La Roche, Inc. Medical (PDF – 4MB) Clinical pharmacology (PDF – 1MB) Statistical (PDF -610KB) BPCA Carbinoxamine maleate – Karbinal ER Tris Pharma, Inc. Medical (PDF – 1.4MB) Clinical pharmacology (PDF – 500KB) None PREA Ceftaroline fosamil – Teflaro  Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC Medical (PDF – 10.9MB)

Medical CTDL (PDF -1.5MB)

Clinical pharmacology (PDF – 3MB) Statistical (PDF -1.2MB) BOTH Cetirizine ophthalmic solution – Zerviate Nicox Ophthalmics, Inc.

Medical Resubmission (PDF – 231 KB)

Medical (PDF – 4.9 MB)

Clinical pharmacology (PDF – 279 KB) Statistical (PDF – 580 KB) BOTH Ciclesonide – Zetonna Takeda GmbH

Medical (PDF – 5MB)

Clinical pharmacology (PDF -1.3MB) Statistical (PDF -674KB) PREA Cinacalcet hydrochloride – Sensipar  

CDTL (PDF – 2.2 MB)

Medical (PDF – 4.1 MB)

Clinical pharmacology (PDF – 5.6 MB) Statistical (PDF – 957 KB) PREA Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% – Otovel Otic Solution Laboratorios SALVAT, S.A. Medical (PDF – 4MB) Clinical pharmacology (PDF -632KB) Statistical (PDF -2MB) PREA Ciprofloxacin otic suspension – Otiprio  Otonomy, Inc. Medical (PDF –  233 KB) Clinical pharmacology (PDF – 79 KB) Statistical (PDF –  213 MB PREA 6% Ciprofloxacin Otic Suspension – Otiprio Otonomy, Inc. Medical (PDF – 2.3MB) Clinical pharmacology (PDF -97KB) Statistical (PDF -896KB)

Addendum (PDF -157KB

PREA Ciprofloxacin ophthalmic solution – Ciloxan Novartis Pharmaceuticals Corporation Medical (PDF – 110 KB) None None BPCA  Clonidine – Kapvay Concordia Pharms Inc. Medical (PDF – 2.6MB) None Statistical (PDF -2MB) PREA Crisaborole Ointment, 2% –  Eucrisa Anacor Pharmaceuticals Inc. CDTL Review (PDF – 2MB)

Medical (PDF – 12MB)

Clinical pharmacology (PDF – 7MB) Statistical (PDF – 1MB) PREA Cysteamine bitartrate – Procysbi Raptor Pharmaceuticals, Inc. Medical (PDF -12MB) Clinical pharmacology (PDF -1.3MB)

Clinical pharmacology addendum (PDF -420KB)

None BPCA Cysteamine bitartrate – Procysbi Horizon Pharma USA, Inc.
  Medical (PDF – 2 MB) Clinical pharmacology (PDF – 1.2MB) Statistical (PDF – 1MB) BPCA Dapsone – Aczone Allergan, Inc. Medical (PDF – 3.5 MB) Clinical pharmacology (PDF –  2.6 MB) Statistical (PDF -1.3 MB) PREA Daptomycin – Cubicin Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. Medical (PDF – 505 KB) Clinical pharmacology (PDF – 1.8 MB)

Statistical (PDF -1.9 KB)

Statistical Addendum (PDF – 96 KB)

PREA Daptomycin – Cubicin Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. Medical (PDF – 389 KB)

Clinical pharmacology (PDF – 991 KB) 
 

Clinical pharmacology Addendum (PDF – 80 KB)

Statistical (PDF – 374 KB) PREA  Darbepoetin alfa – Aranesp Amgen Inc. Medical (PDF -1.6MB) None Statistical (PDF -280KB) BPCA Darunavir – Prezista Janssen Products, L.P. Medical (PDF -1MB) Clinical pharmacology (PDF -1MB) None PREA Darunavir – Prezista Janssen Products, L.P. None Clinical pharmacology (PDF -352KB) None PREA Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide – Symtuza  Janssen Products, L.P. Multi-disciplinary review (PDF – 8 MB) None None  PREA Decitabine – Dacogen  Eisai Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -1MB) None BPCA Deferasirox – Exjade Novartis Pharmaceuticals Corporation Medical (PDF -9MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -2MB) BPCA Deferasirox – Jadenu NEW Novartis Pharmaceuticals Corporation CDTL Review (PDF- 843 KB)

Medical (PDF- 795 KB)

Clinical pharmacology (PDF – 180 KB) None BPCA Desvenlafaxine – Pristiq Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

Medical (PDF – 103 KB)

Medical (PDF – 622 KB)

Clinical pharmacology (PDF – 1.5 MB) Statistical (PDF –  1.5 MB) PREA Dexlansoprazole – Dexilant Takeda Pharmaceuticals USA Inc. CDTL Review (PDF-661KB)

Medical (PDF-5MB)

Clinical pharmacology (PDF-1MB) Statistical (PDF-50KB) PREA Dexmedtomidine hydrochloride – Precedex Hospira Medical (PDF -5MB) Clinical pharmacology (PDF -3.8MB) Statistical (PDF -1MB) BPCA Difluprednate ophthalmic emulsion – Durezol Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd Medical (PDF -748KB) Clinical pharmacology (PDF -40KB) Statistical (PDF -479KB) BPCA Doxycycline hyclate – LymePak Chartwell Pharma NDA B2 Holdings, LLC
  Medical (PDF – 1 MB) None None PREA Dolutegravir – Tivicay ViiV Healthcare Medical (PDF -7.8MB) Clinical pharmacology (PDF -10.8MB) Statistical (PDF -4MB) PREA Dolutegravir – Tivicay  ViiV Healthcare Medical (PDF -1.6MB)

CDTL Review (PDF -932KB)

Clinical pharmacology (PDF -2.2MB) None PREA Doxycycline hyclate delayed-release – Doryx Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC Medical (PDF -241KB) Clinical pharmacology (PDF -89KB) Statistical (PDF -131KB) PREA Duloxetine – Cymbalta Eli Lilly and Company, Inc. Medical (PDF -2.2MB) Clinical pharmacology (PDF -197KB) Statistical (PDF -2.8MB) PREA Duloxetine hydrochloride – Cymbalta Eli Lilly and Company Medical (PDF -8MB) Clinical pharmacology (PDF -959KB) Statistical (PDF -665KB) BPCA Dupilumab – Dupixent Regeneron Pharmaceuticals Medical (PDF – 6MB) None None PREA Econazole nitrate – Ecoza AmDerma Pharmaceuticals, LLC Medical (PDF -2MB) Clinical pharmacology (PDF -2.5MB) Statistical (PDF -422KB) PREA Efavirenz, lamivudine, tenofovir – Symfi Lo  Mylan Pharmaceuticals, Inc. Medical (PDF – 129 KB) Clinical pharmacology (PDF – 1 MB) None PREA Efavirenz, lamivudine, tenofovir Disoproxil Fumarate – Symfi   Mylan Pharmaceuticals, Inc. Medical (541 – KB) None None PREA Efavirenz, Lamivudine and Tenofovir disoproxil fumarate Aurobindo Pharma Limited, India DD Review (PDF – 65 KB) Clinical pharmacology (PDF – 788 KB) None PREA Efavirenz – Sustiva Bristol-Myers Squibb Company Medical (PDF -1.9MB) Clinical pharmacology (PDF -9.3MB) None BPCA Eltrombopag – Promacta  Novartis Pharmaceuticals Corporation Medical (PDF -3.5MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -1MB) BPCA Eltrombopag – Promacta    Novartis Pharmaceuticals Corporation Medical (PDF – 58 KB) None None PREA  Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide – Genvoya Gilead Sciences, Inc. Medical (PDF -13.4MB) Clinical pharmacology (PDF -24.2MB) Statistical (PDF -2.2MB) PREA Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide – Genvoya Gilead Sciences, Inc. Medical (PDF – 642 KB) Clinical pharmacology (PDF – 242 KB) None PREA Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate – Stribild Gilead Sciences, Inc. CTDL Review (PDF -359KB) Clinical pharmacology (PDF – 462KB) None PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide – Odefsey Gilead Sciences, Inc. Medical (PDF -310KB)

CTDL Review (PDF -578KB)

Clinical pharmacology (PDF -5MB)

Clinical pharmacology addendum (PDF -297KB)

None PREA Emtricitabine, Rilpivirine, and Tenofovir alafenamide – Descovy Gilead Sciences, Inc. Medical (PDF -1.27MB)

Addendum (PDF -572KB)

Clinical pharmacology (PDF -7.6MB) Statistical (PDF -1.9MB) PREA Emtricitabine and tenofovir alafenamide – Descovy Gilead Sciences, Inc. Medical (PDF – 642 KB) Clinical pharmacology (PDF -145KB) None PREA Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate – Complera Gilead Sciences, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -145KB) None PREA Emtricitabine and Tenofovir disoproxil fumarate – Truvada  Gilead Sciences, Inc. Medical (PDF -501KB) Clinical pharmacology (PDF -189KB) None PREA Entecavir – Baraclude Bristol-Myers Squibb Company Medical (PDF -3.4MB) Clinical pharmacology (PDF -3MB) Statistical (PDF -660KB) BPCA Epinephrine – Auvi-Q Kaleo, Inc. Medical (PDF – 1.8 MB) None None PREA Erlotinib – Tarceva OSI Pharmaceuticals, LLC Medical (PDF -6.2 MB) Clinical pharmacology (PDF -2.2MB) None BPCA Escitalopram oxalate – Lexapro Forest Laboratories, Inc. Medical (PDF -218KB) None None PREA Eslicarbazepine acetate – Aptiom Sunovion Pharmaceutical Inc. CDTL Review (PDF – 593 KB)

Medical (PDF – 5 MB)

Clinical pharmacology (PDF – 2.9 KB) None PREA Eszopiclone – Lunesta Sunovion Pharmaceuticals, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -883KB) None BPCA Etanercept – Enbrel Immunex  Corporation, a wholly-owned subsidiary of Amgen Inc.

Medical (PDF – 4.8 MB)

DD Review (PDF – 568 KB)

CDTL Review PDF – 504 KB)

Clinical pharmacology  (PDF – 702 KB) Statistical (PDF – 444 KB) PREA Etanercept-szzs – Erelzi Sandoz Inc. Medical (PDF – 1.7 MB) Clinical pharmacology (PDF – 4.7 MB) Statistical (PDF – 432 KB) PREA Etravirine – Intelence Janssen Products, LP Medical (PDF -1.4MB) Clinical pharmacology (PDF -1.7MB) None BOTH Etravirine – Intelence Janssen Products, LP Medical (PDF -1 MB) Clinical pharmacology (PDF – 896 KB) None BOTH Everolimus tablets for oral suspension – Afinitor Disperz Novartis Pharmaceuticals Corporation Medical (PDF -10MB) Clinical pharmacology (PDF -2MB) None BPCA Filgrastim-sndz – Zarxio Sandoz, Inc. Medical (PDF -3.8MB)

DD Review  (PDF -86KB)

TL Review (PDF -422KB)

Clinical pharmacology (PDF -2.75MB)

Addendum (PDF – 1.1MB)

Statistical (PDF -6742KB) PREA Filgrastim-aafi – Nivestym  Hospira, Inc.

CDTL Review (PDF – 746 KB)

Medical (PDF – 245 KB)

Clinical pharmacology  (PDF – 661 KB) Statistical (PDF – 377 KB) PREA  Finafloxacin otic suspension – Xtoro Alcon Research, Ltd. Medical (PDF -6.8MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -3.2MB) BPCA Fingolimod – Gilenya  Novartis Pharmaceuticals Corporation

CDTL Review (PDF – 2 MB)

Medical (PDF – 3.8 MB)

Clinical pharmacology (PDF -2MB) Statistical (PDF -3.2MB) BOTH Fluticasone furoate inhalation powder – Arnuity Ellipta GlaxoSmithKline Medical (PDF -8.6MB) Clinical pharmacology (PDF -5.7MB) Statistical (PDF -1.9) PREA Fluticasone furoate – Arnuity Ellipta GlaxoSmithKline Medical (PDF – 956 KB) Clinical pharmacology (PDF – 2 MB) Statistical (PDF – 507 KB) PREA  Fluticasone propionate Lotion – Cutivate Fougera Pharmaceuticals Inc. Medical (PDF -3MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -317MB) PREA Fluticasone propionate Lotion – Cutivate Fougera Pharmaceuticals Inc. Medical (PDF -1.2MB) Clinical pharmacology (PDF -1.4MB) None PREA Fluticasone propionate/salmeterol xinafoate – Advair HFA GlaxoSmithKline Medical (PDF -1 MB) Clinical pharmacology (PDF -267KB) Statistical (PDF -52 KB) PREA Fluticasone propionate – ArmonAir RespiClick Teva Pharmaceutical Industries Ltd. Medical (PDF -10 MB) Clinical pharmacology (PDF – 4.3MB) Statistical (PDF -1.2 KB) PREA Fluticasone propionate/salmeterol – AirDuo Teva Pharmaceutical Industries Ltd. Medical (PDF -10 MB) Clinical pharmacology (PDF – 4.3 MB) Statistical (PDF -1.2 KB) PREA Fosaprepitant – Emend   Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Medical (PDF – 2 MB) Clinical pharmacology (PDF –  7 MB) Statistical (PDF – 662 KB) BPCA Fosphenytoin sodium – Cerebyx Parke-Davis, a Division of Pfizer, Inc. CDTL Review (PDF – 390 KB)

Medical (PDF – 1.5 MB)

Clinical pharmacology (PDF – 5 MB) None PREA Gadobutrol – Gadavist Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF -958KB) Clinical pharmacology (PDF -2.2MB) Statistical (PDF -422 KB) PREA Gadobutrol – Gadavist Bayer Healthcare Pharmaceuticals, Inc. Medical (PDF -7MB) None Statistical (PDF -782 KB) PREA Gadoterate meglumine – Dotarem Guerbet LLC Medical (PDF -3MB) Clinical pharmacology (PDF -768KB) Statistical (PDF -1.2 MB) PREA Gadoterate meglumine – Dotarem Guerbet LLC Medical (PDF 1.3 MB) Clinical pharmacology (PDF – 1.5 MB) Statistical (PDF – 398 KB) PREA Gadoxetate disodium – Eovist  Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF -1.2MB) Clinical pharmacology (PDF -1.5MB) None PREA Gatifloxacin ophthalmic solution – Zymar Allergan, Inc. Medical (PDF – 78 KB) None None BPCA Glycopyrronium – Qbrexza  Dermira, Inc.
  Medical (PDF –  6 MB) None None PREA Golimumab – Simponi Janssen Biotech, Inc.

Medical (PDF – 3.1 MB)

CTDL Review (PDF – 480 KB)

Clinical pharmacology (PDF – 307 KB) Statistical (PDF – 1.1 MB) PREA Guanfacine – Intuniv Shire Medical (PDF -2.3MB)

CTDL Review (PDF -2.56KB)

Clinical pharmacology (PDF -352KB) Statistical (PDF -708KB) Both Guanfacine – Intuniv Shire Medical (PDF -3MB) Clinical pharmacology (PDF -667KB) Statistical (PDF -3MB) PREA Ibuprofen – Caldolor Cumberland Pharmaceuticals, Inc. DD Summary Review (PDF -669KB)

Medical (PDF -3MB)
 

Clinical pharmacology (PDF -3.7MB) Statistical (PDF -378KB) PREA Indocyanine green for Injection – Spy Agent Green Novadaq Technologies ULC Medical (PDF – 4 MB) None None PREA Indocyanine green for Injection – Spy Agent Green NEW Novadaq Technologies ULC Medical (PDF – 4 MB) None None PREA Infliximab-dyyb – Inflectra Celltrion, Inc. Medical (PDF -5.3MB)

Addendum (PDF – 1MB)

None Statistical (PDF -2MB) PREA Infliximab-abda – Renflexis Samsung Bioepsis Co., Ltd

CDTL Review (PDF – 1 MB)

Medical (PDF – 3.5 MB)

Medical 2(PDF – 267 KB)

Medical 3 (PDF – 93 KB)

Clinical pharmacology (PDF – 7.7 MB)

Statistical (PDF – 959 KB)

Statistical 2 (PDF – 602 KB)

PREA Insulin Degludec – Tresiba Novo Nordisk Inc. CDTL Review (PDF –  7MB)

Medical (PDF – 7 MB)

Clinical pharmacology (PDF –  4MB) Statistical (PDF – 905KB) PREA Insulin Degludec / Insulin Aspart) – Ryzodeg Novo Nordisk Inc. Medical (PDF – 7 MB) Clinical pharmacology (PDF –  4 MB) Statistical (PDF – 905 KB) PREA Iodixanol – Visipaque

GE HealthCare Inc.

CDTL Review (PDF –  2.4 MB)

Medical (PDF – 1.9  MB)

Clinical pharmacology (PDF –  988 KB) Statistical (PDF – 1.8 MB) PREA Iohexol – Oraltag Interpharma Praha, a.s. Medical (PDF -91 KB) Clinical pharmacology (PDF – 294 KB) Statistical (PDF – 98 KB) PREA Ipilimumab – Yervoy  Bristol-Myers Squibb Company Medical (PDF  5.5 MB) Clinical pharmacology (PDF – 1.6 MB) None BPCA Iron Sucrose Injection, USP – Venofer Luitpold Pharmaceuticals, Inc. Medical (PDF -2 MB) Clinical pharmacology (PDF – 114 KB) Statistical (PDF – 576 KB) PREA Kit for the Preparation of Technetium Tc 99m Pentetate Injection – Draximage  Jubilant DraxImage, Inc
  Medical (PDF – 2 MB) None Statistical (PDF -3 76KB) PREA Lacosamide – Vimpat  UCB, Inc.

CDTL Review (PDF – 371 KB)

Medical (PDF – 915 KB)

Clinical pharmacology (PDF – 2 MB) None

PREA

Lamivudine – Epivir ViiV Healthcare Company Medical (PDF -4.2 MB) Clinical pharmacology (PDF – 3 MB)   PREA Lamivudine and Raltegravir – Dutrebis Merck Sharp & Dohme Corp. Medical (PDF -1 MB) Clinical pharmacology (PDF – 6.4 MB) None PREA Lamivudine and tenofovir – Cimduo  Mylan Pharmaceuticals India Medical (PDF – 73 KB) Clinical pharmacology (PDF –  1 MB) None PREA Lamivudine and tenofovir disoproxil fumarate – Temixys Celltrion, Inc. Medical (PDF –  20 KB)

Clinical pharmacology addendum (PDF –  166 KB)

Clinical pharmacology (PDF –  1 MB)

None PREA Lamotrigine – Lamictal  GlaxoSmithKline LLC Medical (PDF -18 MB) Clinical pharmacology (PDF – 793 KB) Statistical (PDF – 1.8 MB) PREA Ledipasvir-sofosbuvir – Harvoni Gilead Sciences, Inc. Medical and CDTL (PDF – 1.5 MB) Clinical pharmacology (PDF – 539 KB) Statistical (PDF – 205 KB) PREA Levalbuterol hydrochloride – Xopenex Oak Pharmaceuticals Medical (PDF -8.3 MB) Clinical pharmacology (PDF – 3.9 MB) Statistical (PDF – 2 MB) PREA Levalbuterol tartrate – Xopenex HFA Sunovion Pharmaceuticals Inc. Medical (PDF -3.9 MB) Clinical pharmacology (PDF – 1.2 MB) Statistical (PDF 1.3 MB) PREA Levetiracetam – Keppra Extended Release Tablets UCB, Inc. DD Summary Review (PDF – 202KB)

CDTL Review (PDF – 371 KB)

Medical (PDF – 327KB)

Clinical pharmacology (PDF – 1.2 MB) None PREA Levonorgestrel – Liletta Medicines360 Medical (PDF – 8.8 MB) Clinical pharmacology (PDF – 1M B)

Clinical pharmacology (PDF – 2.4 MB)

Statistical (PDF – 1.5 MB) PREA Levonorgestrel/ethinyl estradiol and ethinyl estradiol – Quartette Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF -6MB) Clinical pharmacology (PDF – 4 MB)

Clinical pharmacology addendum (PDF – 89KB)

Statistical (PDF – 1MB) PREA Levonorgestrel-releasing intrauterine system – Skyla Bayer HealthCare Pharmaceuticals, Inc. Medical (PDF – 8MB) Clinical pharmacology (PDF – 4MB) Statistical (PDF – 424 KB) PREA Levothyroxine sodium oral solution – Tirosint-SOL Cromsource, Inc.

CDTL Review (PDF – 461 KB)

Medical (PDF – 2.8 MB)

Clinical pharmacology (PDF – 1.8 MB) None PREA Llisdexamfetamine dimesylate – Vyvanse  Shire Development, LLC Medical (PDF –  218 KB) Clinical pharmacology (PDF – 1 MB) None PREA Lisdexamfetamine mesylate – Vyvanse Shire Medical (PDF –  2.4 MB) None Statistical (PDF – 1 MB) PREA Loteprednol –  Lotemax  Bausch & Lonb Inc.

Medical (PDF –  318 KB)

Medical (PDF –  218 KB)

None Statistical (PDF – 3 MB) PREA Lopinavir / Ritonavir – Kaletra AbbVie Inc. Medical (PDF – 5.8 MB) Clinical pharmacology (PDF -2.3 MB) Statistical (PDF – 1.9 MB) PREA Lubiprostone – Amitizia Sucampo Pharmaceuticals Inc. Medical (PDF – 11 MB) Clinical pharmacology (PDF – 1 MB) Statistical (PDF – 1 MB) PREA Luliconazole – LuzuTM Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC

CDTL (PDF – 358 KB) 

CDTL  (PDF – 372 KB) 

Medical (PDF – 306 KB)

Medical (PDF – 616 KB)

Clinical pharmacology (PDF -1 MB) 

Clinical pharmacology (PDF – 423 KB)

Statistical (PDF – 207 KB) PREA Lurasidone hydrochloride – Latuda Sunovion Pharmaceuticals, Inc. Medical (PDF –  6 MB)
Medical (PDF –  6 MB) Clinical pharmacology (PDF – 2 MB) Statistical (PDF –  368 KB)
Statistical (PDF – 254 KB) PREA Lurasidone hydrochloride – Latuda NEW Sunovion Pharmaceuticals, Inc.

CDTL (PDF – 461 KB) 

Medical (PDF – 1 MB)

Clinical pharmacology (PDF – 403 KB) Statistical (PDF – 403 KB) PREA Maraviroc – Selzentry Viiv Healthcare Medical (PDF – 1.0 MB) Clinical pharmacology (PDF – 2.8 MB) None PREA Memantine hydrochloride – Namenda XR Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) Medical (PDF – 2.1 MB) Clinical pharmacology (PDF – 956 KB) Statistical (PDF – 1.1 MB) BPCA Mepolizumab – Nucala GlaxoSmithKline LLC Medical (PDF – 8 MB) Clinical pharmacology (PDF – 6 MB)

Clinical pharmacology addendum (PDF -425KB)

Statistical (PDF – 1.4 MB) PREA Mesalamine – Asacol HD Warner Chilcott Medical (PDF – 6MB) Clinical pharmacology (PDF – 3.2 MB)

Clinical pharmacology (PDF – 518 KB)

Statistical (PDF -499KB) PREA Mesalamine  – Canasa Forest Laboratories Medical (PDF – 6 MB) Clinical pharmacology (PDF – 251KB) Statistical (PDF – 344 KB) PREA Mesalamine – Delzicol Warner Chilcott LLC Medical (PDF – 707 KB)

Medical Addendum(PDF – 495 KB)

Clinical pharmacology (PDF -116KB) None PREA Mesalamine – Delzicol  Warner Chilcott (US), LLC Medical (PDF – 4.7 MB) Clinical pharmacology (PDF – 729 KB) Statistical (PDF – 1.1KB) PREA 10% Methyl salicylate, 3% L-menthol – Salonpas Pain Relief  Hisamitsu Pharmaceutical Co., Inc. Medical (PDF – 998 KB)

Medical (PDF – 3 MB)

Clinical pharmacology (PDF – 2.6 MB) Statistical (PDF – 1.4 MB) PREA Methylphenidate hydrochloride extended-release – Aptensio XR Rhodes Pharmaceuticals L.P. Medical (PDF – 2.3 MB) Clinical pharmacology (PDF – 3.6M B) Statistical (PDF – 1.1 MB)
Statistical (PDF – 629 KB) PREA Methylphenidate hydrochloride – Quillivant XR NextWave Pharmaceuticals, Inc. Medical (PDF – 26 KB) Clinical pharmacology (PDF – 588 KB) Statistical (PDF – 380 KB) PREA Methylphenidate hydrochloride extended release chewable tablets – QuilliChew ER  Pfizer Inc. CTDL Review (PDF -1.3MB)

Medical (PDF – 4.8 MB)

Clinical pharmacology (PDF -2.9MB) Statistical (PDF -498KB) PREA Methylphenidate hydrochloride – Jornay PM  Ironshore Pharmaceuticals & Development, Inc. Medical (PDF – 4.8 MB) Clinical pharmacology (PDF – 2.1 MB) Statistical (PDF – 921 KB) PREA Methylphenidate extended-release orally disintegrating tablets – Cotempla XR-ODT  Neos Therapeutics, Inc.

Medical (PDF – 5.7 MB)

Medical (PDF – 1.2 MB)

Clinical pharmacology (PDF – 2.1 MB)

Clinical pharmacology (PDF – 2.1 MB)

Statistical (PDF – 921 KB)

Statistical (PDF – 96 KB)

PREA Methoxy polyethylene glycol-epoetin beta – Mircera Vifor International AG Medical (PDF – 2.3 MB) None

Statistical (PDF – 239 KB)

PREA Metronidazole vaginal gel 1.3% – Nuvessa Chemo Research SL Medical (PDF – 1.2 MB) Clinical pharmacology (PDF – 70 KB) Statistical (PDF – 127 KB) PREA  Micafungin sodium – Mycamine Astellas Pharma US, Inc. Medical (PDF – 2.2 MB)

Clinical pharmacology (PDF – 4.4MB)

Statistical (PDF -987KB) BPCA Mixed salts of a single-entity amphetamine product – Mydayis  Shire Development, LLC.

Medical (PDF – 6.8 MB)

Clinical pharmacology  (PDF -1.8KB) Statistical (PDF -987KB) PREA Mometasone furoate – Asmanex HFA Merck Sharp & Dohme Corp. Medical (PDF -2.7MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -603KB) PREA Mometasone furoate – Asmanex HFA Merck Sharp & Dohm Corp Medical (PDF-1MB) None None PREA Mometasone furoate and formoterol fumarate – Dulera Schering-Plough Medical (PDF-1MB) None None PREA

Moxifloxacin – Avelox

Bayer Pharmaceuticals Medical (PDF- 905KB) Clinical pharmacology (PDF -1.8MB) Statistical (PDF – 760KB) PREA Moxifloxacin ophthalmic solution – Vigamox Alcon Pharmaceuticals, Ltd. Medical (PDF – 434 KB)

DD Summary Review (PDF- 118 KB)

None None BPCA Naftifine hydrochloride – Naftin Merz Pharmaceuticals, LLC Medical (PDF -488KB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF – 188KB) PREA Naftifine hydrochloride – Naftin Cream, 2% Merz Pharmaceuticals, LLC Medical (PDF – 1.2MB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF – 822KB)  PREA Naloxone hydrochloride – Narcan Nasal Spray Adapt Pharma Operations Limited DD Summary Review(PDF -1.2MB)

CTDL Review (PDF -3MB)

Clinical pharmacology (PDF -1.5MB) None PREA Naproxen sodium 220 mg and Diphenhydramine hydrochloride – Aleve PM Bayer HealthCare, LLC – Consumer Care Medical (PDF -1MB) Clinical pharmacology (PDF -1.7MB) Statistical (PDF -1.3MB) PREA Naproxen and esomeprazole magnesium – Vimovo  Horizon Pharma Inc. Medical (PDF – 3.8 MB) Clinical pharmacology (PDF -2.3 MB) None PREA Neostigmine methylsulfate – Bloxiverz Eclat Pharmaceuticals, LLC Medical (PDF -7.7MB) Clinical pharmacology (PDF -2MB) None PREA Nevirapine – Viramune XR Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -446KB) Statistical (PDF – 723KB) PREA Nilotinib –  Tasigna   Sponsor: Novartis Pharmaceuticals Corporation Medical (PDF – 1.2 MB) Clinical pharmacology (PDF – 1.6 MB) Statistical (PDF – 124 KB) BPCA Nitisinone – NITYR Cycle Pharmaceuticals Ltd. Medical (PDF – 358 KB) Clinical pharmacology (PDF – 3.6 MB) None PREA Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules – Taytulla Warner Chilcott Company, LLC Medical (PDF -1MB) Clinical pharmacology (PDF -3.2MB) Statistical (PDF – 469KB) PREA Obiltoxaximab – Anthim Elusys Theraputics, Inc. Medical (PDF -18MB)

Addendum (PDF -249KB)

Clinical pharmacology (PDF -12MB)

Addendum (PDF -126KB)

Statistical (PDF – 9MB) PREA Ocriplasmin- Jetrea ThromboGenics, Inc. Medical (PDF – 817KB) Clinical pharmacology (PDF – 117KB) Statistical (PDF – 760KB)  PREA Olanzapine and fluoxetine hydrochloride – Symbyax Eli Lilly and Company Medical (PDF -1.3MB) Clinical pharmacology (PDF -1.2MB)

Addendum (PDF – 132KB)

Statistical (PDF – 953KB) PREA Olopatadine – Pazeo Alcon Research LTD Medical (PDF -2.3MB) Clinical pharmacology (PDF -340KB) Statistical (PDF – 4.3KB) BPCA Omalizumab – Xolair Genentech Medical (PDF -6MB) Clinical pharmacology (PDF -1.3MB) Statistical (PDF – 2MB) PREA Omalizumab – Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF-4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF-1 MB)  PREA Omalizumab – Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF – 5MB) None None PREA Omeprazole magnesium – Prilosec  AstraZeneca Pharmaceuticals LP Medical (PDF -908KB) Clinical pharmacology (PDF -1.6MB) None PREA OnabotulinumtoxinA – Botox Allergan

CDTL (PDF – 403 KB)
 

Medical (PDF – 1 MB)

None Statistical (PDF – 173 KB) PREA Oxcarbazepine – Oxtellar XR Supernus Pharmaceuticals, Inc. Medical (PDF -5MB) Clinical pharmacology (PDF -7MB) Statistical (PDF – 482KB) PREA Oxycodone hydrochloride – Oxycontin Purdue Pharma L.P. Medical (PDF -17.6MB) Clinical pharmacology (PDF -2MB) Statistical (PDF – 678KB) BPCA Ozenoxacin – Xepi  Ferrer Internacional S.A. Medical (PDF – 2 MB) Clinical pharmacology (PDF – 1 MB) Statistical (PDF – 524 KB) PREA Palifermin – Kepivance Quintiles, Inc. Medical (PDF -280KB) Clinical pharmacology (PDF -726KB) None PREA Palonosetron hydrochloride – Aloxi Helsinn Healthcare SA Medical (PDF -15MB)

Medical (PDF -2MB)

Clinical pharmacology (PDF -2.3MB) Statistical (PDF – 771KB) BPCA Pancrelipase – Creon AbbVie Inc. Medical (PDF -566KB) None None PREA Pancrelipase – Pancreaze  Janssen Pharmaceuticals, Inc. Medical (PDF -142KB) None None PREA Pancrelipase – Pertzye Digestive Care, Inc. Medical (PDF – 1MB) None None PREA Pancrelipase – Zenpep Aptalis Pharma Limited. Medical (PDF -587KB) None None PREA Paricalcitol – Zemplar AbbVie Inc. Medical (PDF – 3.0MB)

CDTL (PDF – 1.1MB)

Clinical pharmacology (PDF – 1.9MB) Statistical (PDF – 427KB) PREA pegfilgrastim-cbqv –  UDENYCA   
  Coherus BioSciences, Inc

Medical (PDF – 184 KB)

Medical (PDF – 228 KB)

CDTL (PDF – 584 KB)

Clinical pharmacology (PDF – 968 KB) Statistical (PDF – 199 KB) PREA Peginterferon alfa-2a – Pegays Hoffmann-La Roche, Incorporated Medical (PDF – 799 KB) Clinical pharmacology (PDF – 667 KB) Statistical (PDF – 667 KB) PREA Peramivir  – Rapivab BioCryst Pharmaceuticals, Inc. Medical (PDF – 767KB Clinical pharmacology (PDF -468 KB) Statistical (PDF – 767KB) PREA Perampanel – Fycompa Eisai, Inc. Medical (PDF -4.8MB) Clinical pharmacology (PDF -6MB) Statistical (PDF -1.2MB) PREA Perampanel – Fycompa Eisai, Inc. Medical (PDF -2.9MB)
Medical (PDF -1.6MB) Clinical pharmacology (PDF -4MB) Statistical (PDF -1.3MB) PREA Perampanel – Fycompa Eisai Inc. Medical (PDF -2.6MB)

Medical  MTL (PDF -678KB)

Clinical pharmacology (PDF -1.2MB) None PREA Perampanel – Fycompa Eisai Inc. Medical (PDF – 79 KB) Clinical pharmacology (PDF – 86 KB) None PREA Perampanel – Fycompa  Eisai Inc.

CDTL (PDF – 452 KB)

Medical (PDF – 5 MB)

Clinical pharmacology  (PDF – 2.5 MB) None PREA Phentolamine mesylate – OraVerse  Septodont Holding Sas Medical (PDF -2.7MB) None Statistical (PDF -1.4MB) PREA Phenylephrine hydrochloride ophthalmic solution Paragon BioTeck, Inc. Medical (PDF – 1MB) Clinical pharmacology (PDF – 95KB) Statistical (PDF -1MB) PREA Phenylephrine and ketorolac – Omidria  Omeros Corporation CDTL (PDF – 1 MB)
Medical (PDF – 4 MB) None Statistical (PDF – 816 KB) BPCA Posaconazole – Noxafil Merck Sharp & Dohme Corp. Medical (PDF – 3MB) Clinical pharmacology (PDF – 1.2MB) Statistical (PDF – 252KB) PREA Posaconazole – Noxafil Merck Medical (PDF – 602KB) Clinical pharmacology (PDF –  645KB) None PREA Prasugrel – Effient Eli Lilly and Company Medical (PDF – 2MB) Clinical pharmacology (PDF – 911KB) Statistical (PDF -290KB) BPCA Pregabalin – Lyrica Pfizer Medical (PDF –  3.8MB) Clinical pharmacology (PDF – 5.9KB) Statistical (PDF – 825KB) PREA Pregabalin – Lyrica  PF PRISM CV Medical and Statistical (PDF –  1.2 MB) Clinical pharmacology (PDF – 1.3 MB) Medical and Statistical (PDF –  1.2 MB) PREA  Quetiapine fumarate – Seroquel and Seroquel XR AstraZeneca Pharmaceuticals LP

CTDL Review (PDF -1MB)

Medical (PDF – 3MB)

Clinical pharmacology(PDF -1.8MB)

Clinical pharmacology (PDF -739KB)

Statistical (PDF -785KB) PREA Rabeprazole sodium – AcipHex Sprinkle Eisa Inc. Medical (PDF – 3MB) Clinical pharmacology (PDF – 5MB) Statistical (PDF 185KB) BPCA Raltegravir – Isentress Merck Sharp Dohme Corp Medical (PDF -1MB) Clinical pharmacology  (PDF -2.4MB) None PREA Raltegravir – Isentress Merck Sharp Dohme Corp CDTL Review (PDF – 4.5 MB) Clinical pharmacology  (PDF – 5 MB) Statistical (PDF 874 KB) PREA Raltegravir – Isentress   Merck Sharp Dohme Corp Medical (PDF – 1 MB) Clinical pharmacology (PDF – 1 MB) None PREA Reslizumab – Cinqair   Teva Respiratory, LLC Medical (PDF -5MB) Clinical pharmacology (PDF -9MB) Statistical (PDF -1.6MB) PREA Rifapentin – Priftin Sanofi US Services Inc. Medical (PDF -10.1MB) Clinical pharmacology (PDF -5.1MB) Statistical (PDF -3.1MB) PREA Rilpivirine – Edurant  Janssen Products L.P. Medical (PDF -2.3MB) Clinical pharmacology (PDF -138KB) None PREA Risperidone – Risperdal Consta Janssen Pharmaceuticals, Inc. DD Summary Review (PDF -20KB)

CTDL Review (PDF -1MB)

Medical (PDF -670KB)

Medical (PDF -667KB)

None Statistical (PDF -237KB) PREA Rufinamide – Banzel Eisai Inc. Medical (PDF -9.4MB) Clinical pharmacology (PDF -3MB) None BPCA Ruxolitinib – Jakafi Incyte Corporation
  Medical (PDF – 685 KB) Clinical pharmacology (PDF – 533 KB) None BPCA Sapropterin dihydrochloride – Kuvan BioMarin Pharmaceutical Inc. Medical (PDF -3.6MB) Clinical pharmacology (PDF -2.5MB) None BPCA Saquinavir mesylate – Invirase Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -1MB) PREA Sarecycline – Seysara  Allergan, Inc.
  Medical (PDF -1MB) None None PREA Selegiline – Emsam Somerset Pharmaceuticals Medical (PDF -1.1MB)

Medical 2 (PDF -1.2MB)

Medical Secondary 1 (PDF -349KB)

Medical Secondary 2 (PDF -188KB)

None None PREA Segesterone acetate and ethinyl estradiol vaginal systems – Annovera  The Population Council, Inc. Medical (PDF –  5 MB) None None PREA Sevelamer Carbonate – Renvela Genzyme/Sanofi Medical (PDF – 745KB) Clinical pharmacology (PDF –  542KB) Statistical (PDF – 541KB) PREA Sildenafil – Revatio Pfizer, Inc. Medical (PDF – 6MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -508KB) BOTH Sodium oxybate – Xyrem  Jazz Pharmaceuticals Medical (PDF – 7 MB) Clinical pharmacology (PDF – 6 MB) Statistical (PDF – 365 KB) BPCA Sodium picosulfate, magnesium oxide, and anhydrous citric acid – Prepopik Ferring Pharmaceuticals Inc. Medical (PDF – 1 MB) None None PREA  Spinosad – Natroba ParaPRO, LLC Medical (PDF – 854KB) Clinical pharmacology (PDF -171KB) None PREA Sofosbuvir – Sovaldi Gilead Sciences, Inc. Medical and CDTL (PDF – 345 KB) Clinical pharmacology (PDF – 511 KB) None PREA Solifenacin succinate – VESIcare Astellas Pharma Global Development, Inc. Medical (PDF – 2 MB) Clinical pharmacology (PDF – 933KB) Statistical (PDF – 960 KB) BPCA Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension – Lumason Bracco Diagnostics Inc. Medical (PDF – 5.1MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -792KB) PREA Sulfur Hexafluoride Lipid-Type A Microspheres – Lumason Bracco Diagnostics, Inc. Medical (PDF – 3MB)

CDTL (PDF – 1.1MB)

Clinical pharmacology (PDF – 1MB) Statistical (PDF – 859KB) PREA Sumatriptan/Naproxen – Treximet Pernix Therapeutics Medical (PDF -1.8MB) Clinical pharmacology (PDF -2.8MB) Statistical (PDF -843KB)

Statistical Addendum (PDF -702KB)

BPCA Tadalafil – Cialis Eli Lilly and Company Medical (PDF – 1 MB) Clinical pharmacology (PDF – 1.4MB) None BPCA

Tacrolimus – Astagraf XL NEW

Astellas Pharma US, Inc. Medical (PDF – 749 KB) None None PREA Tavaborole – Kerydin  Anacor Pharmaceuticals, Inc. Multi-disciplinary review (PDF – 2.5 MB) None None BPCA Tbo-filgrastim – Granix  Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D

CDTL (PDF –  176 KB)

Clinical (PDF –  196 KB)

Clinical pharmacology  (PDF – 434 KB) None BPCA Tenofovir disoproxil fumarate – Viread Gilead Sciences Medical (PDF – 2.4MB) Clinical pharmacology (PDF – 1.4MB) Statistical (PDF – 1.4MB) PREA Tenofovir disoproxil fumarate – Viread NEW Gilead Sciences CDTL (PDF – 349 KB) Clinical pharmacology (PDF – 180 KB) Statistical (PDF – 148 KB) PREA Tetracaine hydrochloride – None Alcon Research, Ltd. DD Medical Summary  (PDF -1.8MB)

Medical (PDF -1.4MB)

Clinical pharmacology (PDF – 158KB) Statistical (PDF – 2.3MB) PREA Tetracaine HCl and Oxymetazoline HCl – Kovanaze  St. Renatus, LLC Medical (PDF – 11.8MB) Clinical pharmacology (PDF – 11.6MB) Statistical (PDF – 2.4MB) PREA Tiotropium bromide – Spiriva Respimat Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -11.9MB)

Medical Addendum (PDF – 418KB

Clinical pharmacology (PDF – 5.9MB) Statistical (PDF – 1.3MB)

Statistical Addendum (PDF -327 KB)

PREA Tiotropium bromide – Spiriva Respimat  Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF –  4.8MB) Clinical pharmacology (PDF – 2MB) Statistical (PDF – 432K B) PREA Tobramycin 300 mg/4mL inhalation solution – Bethkis Cornerstone Therapeutics Medical (PDF – 5.4MB) Clinical pharmacology (PDF – 78KB) Statistical (PDF – 687 KB) PREA

Tocilizumab – Actemra 

Genentech, Inc.

Medical (PDF – 72 KB)

Medical (PDF – 109 KB)

Clinical pharmacology (PDF –  195 KB) None  PREA

Tocilizumab – Actemra 

Genentech, Inc. Medical (PDF – 8 MB) None None PREA Topiramate – Topamax Janssen Pharmaceuticals, Inc. Medical (PDF – 8.6MB) None Statistical (PDF – 881KB) PREA Trabectedin – Yondelis Janssen Products, LP Medical (PDF – 2.5 MB) Clinical pharmacology  (PDF –  683 KB) None BPCA Tranexamic acid – Lysteda Ferring Pharmaceuticals, Inc. None Clinical pharmacology (PDF – 1.2MB) None PREA Tretinoin lotion – Altreno Dow Pharmaceutical Sciences, Inc. Medical (PDF –  3 MB) None None PREA Valganciclovir hydrochloride – Valcyte Roche Palo Alto LLC c/o Genentech, Inc.orporated Medical (PDF -2 .7MB) Clinical pharmacology (PDF – 6MB) None PREA Ustekinumab – Stelara Janssen Biotech Inc.

CDTL (PDF – 593 KB)

Medical (PDF – 5.2 MB)

Clinical pharmacology (PDF –  3 MB) Statistical (PDF – 275 KB) PREA  Vigabatrin – Sabril Lundbeck LLC. Medical (PDF – 4MB) Clinical pharmacology (PDF – 2.3MB) Statistical (PDF – 698KB) BOTH Voriconazole – Vfend PF PRISM C.V. Medical (PDF –  2.5 MB) Clinical Pharmacology (PDF – 1.4 MB) Statistical (PDF –  439 KB) PREA Zolmitriptan – Zomig  AstraZeneca Pharmaceuticals LP Medical (PDF -4.5MB) None Statistical (PDF -2.9MB) PREA

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Abacavir Glaxo Wellcome, Inc. 8/20/1998 Abatacept Bristol-Myers Squibb Company 9/13/2013 Acamprosate Forest Labs 11/9/2005 Acetaminophen Cadence Pharmaceuticals 8/24/2007 Acetazolamide Wyeth-Ayerst 10/15/1999 Adefovir Gilead Sciences 4/12/2002 Afatinib Boehringer Intelheim Pharmaceuticals, Inc. 4/7/2017 Albuterol Dey, L.P. 10/30/2001 Albuterol  GlaxoSmithKline 12/31/2001 Alendronate Merck Research Laboratories 10/27/2000 Alfuzosin Sanofi-Aventis U.S. LLC 2/21/2006 Aliskiren Novartis Pharmaceuticals 5/13/2008 Almotriptan Pharmacia & Upjohn 10/5/2001 Alogliptin Takeda Pharmaceuticals U.S.A., Inc. 10/1/2013 Alosetron Glaxo Wellcome, Inc. 4/7/2000 Alprazolam Pharmacia & Upjohn 5/21/2003 Amiodarone Wyeth Ayerst 11/5/1999 Amlexanox Block Drug Company, Inc. 3/23/2000 Amlodipine Pfizer, Inc. 2/4/1999 Amlodipine/Benazepril Novartis Pharmaceuticals 12/19/2001 Ammonium Lactate Westwood Squibb 2/22/1999 Amphetamine (mixed salts) Shire Laboratories 5/6/2003 Amprenavir Glaxo Wellcome, Inc. 4/7/1999 Anagrelide  Shire Laboratories 3/27/2003 Anastrozole AstraZeneca Pharmaceuticals LP 5/9/2001 Apixaban Bristol-Myers Squibb Company 3/24/2017 Apremilast Celgene Corporation 5/29/2015 Aprepitant/Fosaprepitant Merck & Company, Inc. 2/2/2009 Argatroban  Encysive Pharmaceuticals 4/2/2003 Aripiprazole Otsuka Pharmaceutical Co., Ltd. 2/11/2003 Asenapine Organon USA, Inc. 9/22/2009 Atazanavir Bristol-Myers Squib 8/2/2001 Atezolizuab Genentech, Inc. 8/10/2016 Atomoxetine Lilly Research Laboratories 10/10/2001 Atorvastatin Warner-Lambert Export, Ltd. 2/16/1999 Atovaquone/Proguanil Glaxo Wellcome, Inc. 1/16/2001 Azelastine ASTA Medica, Inc. 4/16/1999 Azelastine Meda Pharmaceuticals, Inc. 9/6/2013 Azilsartan medoxomil Takeda Pharmaceuticals U.S.A., Inc. 12/6/2012 Azithromycin Pfizer 7/31/2003 Baclofen Schwarz Pharma, Inc. 4/30/2004 Balsalazide Salix Pharmaceuticals 12/17/2001 Beclomethasone Schering Corporation 6/24/1999 Beclomethasone 3M Pharmaceuticals 12/31/2001 Benazepril Novartis Pharmaceuticals 5/27/1999 Bendamustine Cephalon, Inc. 1/19/2010 Besifloxacin Bausch & Lomb, Inc. 1/13/2011 Betamethasone Schering Corporation 7/16/1999 Betaxolol Lorex Pharmaceuticals 2/11/1999 Betaxolol Alcon Laboratories 3/5/2004 Bicalutamide AstraZeneca Pharmaceuticals 4/17/2003 Bictegravir/Emtricitabine/Tenofovir Alafenamide(B/F/TAF) * Gilead Sciences, Inc. 5/26/2017 Bisoprolol Wyeth-Ayerst Laboratories 12/23/1998 Bivalirudin The Medicines Company 5/7/2007 Blinatumomab Amgen, Inc. 11/12/2014 Boceprevir Schering-Plough 10/14/2011 Bortezomib Millenium Pharmaceuticals 4/27/2010 Bosutinib Wyeth Pharmaceuticals, Inc. 7/30/2015 Brimonidine Allergan, Inc. 6/25/1999 Brinzolamide Alcon Laboratories 10/15/1999 Budesonide AstraZeneca Pharmaceuticals, L.P. 12/14/1998 Budesonide/Formoterol AstraZeneca Pharmaceuticals, L.P. 1/28/2011 Buprenorphine NEW Purdue Pharma L.P. 9 Buprenorphine Reckitt Benckiser Pharmaceuticals 4/12/2006 Bupropion Glaxo Wellcome, Inc 7/21/2000 Buspirone Bristol-Myers Squibb Company 10/9/1998 Busulfan Orphan Medical 3/27/2000 C-Urea Meretek Diagnostics, Inc. 6/10/2004 Cabazitaxel Sanofi-Aventis 3/20/2012 Calcipotriene Leo Pharmaceuticals 2/20/2007 Calcitriol Abbott Laboratories 9/17/1999 Calcitriol Galderma Laboratories 10/13/2010 Canagliflozin Janssen Pharmaceuticals, Inc. 3/8/2014 Candesartan Astra Pharmaceuticals 3/15/1999 Capecitabine Hoffmann-La Roche, Inc. 3/16/2005 Carbamazepine Shire Development, Inc. 9/7/2005 Carboplatin Bristol-Myers Squibb Company 4/11/2001 Carfilzomib Onyx Therapeutics, Inc. 3/17/2005 Cariprazine Forest Research Institute 2/3/2017 Carteolol CIBA Vision Corporation 10/15/1999 Carvedilol SmithKline Beecham Pharmaceuticals 12/23/1998 Caspofungin Merck Research Laboratories 1/26/2001 Celecoxib G.D. 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Johnson 10/22/1999 Levofloxacin Santen, Inc. 12/20/2001 Levomilnacipran Forest Laboratories, Inc. 9/5/2014 Levonorgestrel/ethinyl estradiol Duramed Research, Inc. 8/14/2005 Linaclotide Forest Laboratories, LLC 3/11/2016 Linezolid Pharmacia & UpJohn 12/22/1999 Liraglutide Novo Nordisk, Inc. 9/13/2012 Lisdexamfetamine Shire 6/3/2014 Lisinopril Zeneca Pharmaceuticals 12/23/1998 Lisinopril Merck & Co., Inc. 12/23/1998 Lithium Roxane 9/26/2003 Lomitapide Aegerion 1/20/2015 Lopinavir/Ritonavir Abbott Laboratories 3/31/1999 Loratadine Schering Corporation 10/15/1998 Lorazepam Wyeth-Ayerst Research 7/5/2002 Lorcaserin Eisai, Inc. 10/24/2017 Losartan Merck Research Laboratories 7/1/1999 Loteprednol Bausch & Lomb, Inc. 4/26/2013 Lovastatin Merck & Co., Inc. 2/3/1999 Lurasidone Sunovion Pharmaceuticals, Inc. 4/20/2012 Macitentan Actelion Clinical Res., Inc. 4/13/2016 Malathion Taro Pharm, USA, Inc. 4/13/2016 Maraviroc Pfizer, Inc. 11/28/2006 Meloxicam Boehringer Ingelheim Pharmaceuticals 11/22/2004 Memantine Forest Research Institute 1/25/2012 Meropenem AstraZeneca 9/10/2004 Mesalamine Procter & Gamble Pharmaceuticals, Inc. 11/30/2001 Mesalamine Shire 5/2/2014 Metformin Bristol-Myers Squibb Company 6/9/1999 Methazolamide Wyeth-Ayerst Laboratories  10/15/1999 Methotrexate Mayne Pharma (USA) Inc. 7/20/2006 Methylphenidate McNeil Consumer & Specialty Pharm. 6/25/2003 Metipranolol Bausch & Lomb 10/15/1999 Metoclopramide Schwarz Pharma, Inc. 7/20/2005 Metoprolol AstraZeneca, Pharmaceuticals, LP 10/19/1999 Micafungin Astellas Pharma US, Inc. 5/23/2007 Miconazole BioAlliance Pharma 3/8/2012 Midazolam Hoffmann-La Roche, Inc. 7/20/1998 Milnacipran Cypress Bioscience, Inc. 2/2/2009 Milrinone Sanofi Synthelabo, Inc. 1/21/2000 Minoxidil Pharmacia & Upjohn Company 11/8/2000 Mirabegron Astellas Pharma Global Development, Inc. 3/18/2016 Mirtazapine Organon, Inc. 4/28/1999 Modafinil Cephalon, Inc. 6/17/2004 Moexipril Schwarz Pharmaceuticals 3/15/1999 Mometasone Schering Corporation 3/17/1999 Mometasone/Formoterol Merck Sharp & Dohme Corp. 7/23/2012 Montelukast Merck & Co., Inc. 3/4/1999 Morphine Elan Drug Delivery 3/28/2003 Morphine Faulding Pharmaceuticals 3/28/2003 Motexafin Pharmacyclics 12/27/2001 Moxifloxacin Alcon Universal, Ltd. 6/26/2000 NAB-paclitaxel Celgene Corporation 10/29/2014 Nabumetone SmithKline Beecham 3/19/1999 Nateglinide Novartis Pharmaceuticals 12/31/2001 Nefazodone Bristol-Myers Squibb Company 4/28/1999 Nelfinavir Agouron Pharmaceuticals, Inc. 3/29/1999 Nevirapine Boehringer Ingelheim Pharmaceuticals 9/11/1998 Nicardipine PDL BioPharma, Inc. 9/18/2007 Nicotine SmithKline Beecham 12/4/1998 Nilotinib Novartis Pharmaceuticals  6/19/2009 Nitric Oxide INO Therapeutics 4/30/2010 Nivolumab Bristol-Myers Squibb Company 9/11/2014 Nizatidine Reliant Pharmaceuticals 6/22/2001 Norfloxacin Merck & Co., Inc. 11/1/1999 Norgestimate/ethinyl estradiol R.W. 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Prism CV 8/12/2015 Tolterodine Pharmacia & Upjohn Company 1/23/2001 Tolvaptan Otsuka Pharmaceutical Company, Ltd. 6/15/2011 Topiramate The R.W. Johnson 7/9/2004 Topotecan SmithKline Beecham 5/16/2000 Tramadol R.W. Johnson 3/30/1999 Trametinib Novartis Pharmaceuticals Corporation 3/1/2016 Valacyclovir GlaxoSmithKline 8/2/2001 Valganciclovir Roche Pharmaceuticals 6/20/2001 Valsartan Novartis Pharmaceuticals 12/19/2000 Varenicline Pfizer, Inc. 6/12/2007 Velpatasvir(VEL) Gilead Sciences, Inc. 9/2/2016 Venlafaxine Wyeth-Ayerst Laboratories  4/28/1999 Verapamil Elan Pharmaceutical Research Corp. 2/3/1999 Vigabatrin Lundbeck, Inc. 8/25/2011 Vilazodone Forest Labs 11/20/2012 Vinorelbine Glaxo Wellcome, Inc. 1/9/2001 Voriconazole Pfizer Global Research & Development 12/21/2001 Vortioxetine Takeda Pharms, USA 9/24/2015 Zafirlukast Zeneca Pharmaceuticals 1/4/1999 Zanamivir Glaxo Wellcome, Inc 12/29/1998 Ziprasidone Pfizer, Inc. 2/11/2003 Zoledronic acid Novartis Pharmaceuticals Corporation 8/19/2002 Zolmitriptan Zeneca Pharmaceuticals 3/26/1999 Zolpidem Sanofi-Synthelabo Research 12/27/2005 Zonisamide Elan Pharmaceuticals, Inc. 5/21/2001

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050002.htm

Pediatric Exclusivity Statistics

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DCRP (Division of Cardiovascular Renal Products) 89 50 DNP (Division of Neurology Products) 82 Updated 40 DPP (Division of Psychiatry Products) 64  47 DOP1 (Division of Oncology Products 1) 33 21 DOP2 (Division of Oncology Products 2) 60 39 Updated DHP (Division of Hematology Products) 97 Updated 38 DMIP (Division of Medical Imaging Products ) 14 7 DAAAP (Division of Analgesia, Anesthesia and Addiction Products) 80 40 DGIEP (Division of Gastroentereology and Inborn Products) 78 28 DMEP (Division of Metabolism and Endocrinology Products) 140 47 DAIP (Division of Anti-Infective Products) 33 11 DAVP (Division of Anti-Viral Products) 68 54 DDDP (Division of Dermatology and Dental Products) 61 Updated 26 Updated DNDP (Division of Nonprescription Drug Products) 10 5 DPARP (Division of Pulmonary, Allergy and Rheumatology Products) 64 Updated 34 DBRUP (Division of Bone, Reproductive and Urologic Products) 37 14 DTOP (Division of Transplant and Ophthalmology Products) 42 54 TOTAL 1052 Updated 549 Updated

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm

Estudio de seguridad revela el riesgo de coágulos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará

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[2-25-2019] La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de Estados Unidos está alertando al público acerca de un ensayo clínico de seguridad que concluyó que existe un aumento en el riesgo de coágulos de sangre en los pulmones y muerte cuando se utilizó una dosis diaria de 10 mg dos veces al día de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide (AR). La FDA no ha aprobado esta dosis diaria de 10 mg dos veces al día para AR; esta dosis sólo está aprobada en la pauta posológica para pacientes con colitis ulcerosa.

En este ensayo clínico de seguridad exigido por la FDA cuando se aprobó tofacitinib para la AR, Pfizer, el fabricante del medicamento, está cambiando a los pacientes que tomaban la dosis diaria más alta de 10 mg dos veces al día a la dosis más baja, que actualmente cuenta con aprobación, de 5 mg diarios dos veces al día. Este ensayo continuará y se espera que finalice para finales de 2019. Estamos trabajando con el fabricante para evaluar otra información de seguridad que está disponible actualmente para tofacitinib y comunicaremos al público cualquier información nueva basándonos en la revisión en curso.

Los profesionales de atención médica deben seguir las recomendaciones en la información de prescripción de tofacitinib para la enfermedad específica que están tratando. Monitoree a los pacientes para detectar indicios y síntomas de embolia pulmonar, y avíseles que deben buscar atención médica de inmediato si presentan cualquiera de ellos.

Los pacientes no deben dejar de tomar o cambiar la dosis de tofacitinib sin primero hablar con su profesional de atención médica, ya que hacerlo puede empeorar su afección. Los pacientes que toman tofacitinib deben buscar atención médica de inmediato si experimentan síntomas de un coágulo de sangre en los pulmones u otros síntomas inusuales como:

  • Falta de aliento o dificultad para respirar repentinos
  • Dolor de pecho o dolor en la espalda
  • Tos con sangre
  • Sudoración excesiva
  • Palidez o color azulado de la piel

Tofacitinib actúa reduciendo la actividad del sistema inmunitario. Se aprobó por primera vez en 2012 para tratar a pacientes adultos con AR que no respondían bien al medicamento metotrexato. En la AR, el cuerpo ataca sus propias articulaciones, ocasionándoles dolor, hinchazón y pérdida de funciones. En 2017, aprobamos el medicamento para tratar pacientes con una segunda afección, la artritis psoriásica, que no tuvieron buena respuesta al metotrexato o a otros medicamentos similares llamados fármacos antirreumáticos modificadores de la enfermedad (FARME) no biológicos. La artritis psoriásica es un trastorno que también ocasiona dolor articular e hinchazón. En 2018, aprobamos tofacitinib para tratar una afección llamada colitis ulcerativa, que es una enfermedad inflamatoria crónica de los intestinos que afecta al colon.

Cuando la FDA aprobó tofacitinib por primera vez, exigimos la realización de un ensayo clínico entre pacientes con AR para evaluar el riesgo de eventos cardíacos, cáncer e infecciones oportunistas con el medicamento en dos dosis (10 mg diarios dos veces al día y 5 mg diarios dos veces al día) en combinación con metotrexato, comparándolo con otro medicamento llamado inhibidor del factor de necrosis tumoral (FNT). Se exigió que los pacientes con AR en el estudio tuvieran al menos 50 años y al menos un factor de riesgo cardiovascular. Durante el análisis más reciente del estudio, un comité de monitoreo de seguridad de datos externo encontró un aumento de la ocurrencia de coágulos de sangre en los pulmones y muerte en pacientes tratados con tofacitinib de 10 mg dos veces al día en comparación con pacientes tratados con tofacitinib de 5 mg dos veces al día o un inhibidor del FNT.

Para ayudar a la FDA a realizar el seguimiento de cuestiones de seguridad con los medicamentos, alentamos a los pacientes y profesionales de atención médica a informar los efectos secundarios que involucren tofacitinib u otros medicamentos al programa MedWatch de la FDA, usando la información del recuadro que aparece al final de la página donde dice “Comuníquese con la FDA”.

https://www.fda.gov/Drugs/DrugSafety/ucm632779.htm

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