Drug Information

June 6, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement – 06/06/2019 – 06/06/2019

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Date:
June 06, 2019
Time:
June 06, 2019

UPDATED INFORMATION (as of May 23, 2019):

The meeting time has been changed for the June 6, 2019 Antimicrobial Drugs Advisory Committee meeting. The meeting time has changed from 8:30 a.m. – 4:30 p.m. to 8:00 a.m. – 4:00 p.m. Additionally, the Open Public Hearing time has changed from 1:30 p.m. – 2:30 p.m. to 1:00 p.m. – 2:00 p.m. All other information remains the same.


ORIGINAL INFORMATION

Center Date Time Location
CDER June 6, 2019 8:30 a.m. to 4:30 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) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB).

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-1317. The docket will close on June 5, 2019. Submit either electronic or written comments on this public meeting by June 5, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 5, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 5, 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 May 22, 2019 will be provided to the Committee. Comments received after that date but by June 5, 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-1317 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. to 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 May 14, 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 May 15, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the June 6, 2019 AMDAC meeting. 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: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)

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.


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 agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability 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).

http://www.fda.gov/advisory-committees/advisory-committee-calendar/june-6-2019-antimicrobial-drugs-advisory-committee-meeting-announcement-06062019-06062019

August 7, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement – 08/07/2019 – 08/07/2019

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Date:
August 07, 2019
Time:
August 07, 2019

Center Date Time Location
CDER August 7, 2019 8:30 a.m. to 4:30 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 supplemental new drug application (sNDA) 208215, supplement 12, DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.

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-2779. The docket will close on August 6, 2019. Submit either electronic or written comments on this public meeting by August 6, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 6, 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 July 24, 2019 will be provided to the committee. Comments received after that date but by August 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: 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-2779 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 July 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 July 17, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the August 7, 2019 Antimicrobial Drugs Advisory Committee meeting. 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. Scroll down to the appropriate advisory committee meeting link.

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.

Event Materials


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 agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability 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).

http://www.fda.gov/advisory-committees/advisory-committee-calendar/august-7-2019-antimicrobial-drugs-advisory-committee-meeting-announcement-08072019-08072019

Drug Trial Snapshot: RECARBRIO

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HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.r text

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the RECARBRIO Package Insert for complete information. 

RECARBRIO (imipenem, cilastatin, and relebactam) 
reh-CAR-bree-oh
Merck Sharp & Dohme Corp.
Approval date: July 16, 2019


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

RECARBRIO is a drug for adults who do not have additional options to treat:

  • Complicated urinary tract infection (cUTI) including infection of the kidneys (pyelonephritis) caused by specific bacteria or,
  • Complicated intra-abdominal infections (cIAI) (serious infections that extend into the intra-abdominal cavity and require treatment in the hospital) caused by specific bacteria.

RECARBRIO is a combination of the previously approved drugs (imipenem/cilastatin and a new drug (relebactam). RECARBRIO should only be used when the infection is caused by bacteria or strongly suspected to be caused by bacteria.

How is this drug used?

RECARBRIO is a drug administered by a health care professional directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV, infusion. It takes about 30 minutes to receive a RECARBRIO infusion.

RECARBRIO is given every 6 hours for 4 to 14 days.

What are the benefits of this drug?

In patients who have few or no other treatment options, RECARBRIO treats cIAI and cUTI. 

What are the benefits of this drug (results of trials used to assess efficacy)?

The determination of efficacy of RECARBRIO was supported in part by the previous findings of the efficacy of imipenem/cilastatin for the treatment of cIAI and cUTI. The contribution of relebactam to RECARBRIO was established in vitro and in animal models of infection. RECARBRIO was studied in two, randomized, blinded, active-controlled, trials in adults with cIAI and cUTI. The trials were designed primarily for safety and provided limited efficacy information.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

The trials that evaluated RECARBRIO provided limited benefit information. Therefore, differences in how the drug worked among sex, race, and age subgroups could not be determined.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The trials that evaluated RECARBRIO provided limited efficacy information to determine if there were differences in how well the drug worked in sex, race, and age subgroups. 

What are the possible side effects?

RECARBRIO may cause serious side effects such as severe allergic reactions, seizures, and antibiotic-associated diarrhea called clostridium difficile.

The most common side effects of RECARBRIO are diarrhea, nausea, headache, vomiting and abnormal liver tests.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions in patients from both trials.

Table 2. Adverse Reactions Occurring in Greater Than or Equal to 1% of Patients in Trials 1 and 2

Disorders

RECARBRIOa
(N=216)
n (%)

Imipenem/Cilastatin plus placebob
(N=214)
n (%)

Blood and lymphatic system disorders

​    Anemiac

2 (1%)

4 (2%)

Gastrointestinal disorders

​    Diarrhea

12 (6%)

9 (4%)

​    Nausea

12 (6%)

12 (6%)

​    Vomiting

7 (3%)

4 (2%)

General disorders and administration site conditions

​    Phlebitis/Infusion site reactionsd

5 (2%)

3 (1%)

​    Pyrexia

5 (2%)

3 (1%)

Laboratory Investigations

​    Alanine aminotransferase increased

7 (3%)

4 (2%)

​    Aspartate aminotransferase increased

6 (3%)

3 (1%)

​    Lipase increased

3 (1%)

4 (2%)

​    Blood creatinine increased

1 (<1%)

3 (1%)

Nervous system disorders

​    Headache

9 (4%)

5 (2%)

​    Central nervous system adverse reactionse

2 (1%)

5 (2%)

Vascular disorders

​    Hypertensionf

4 (2%)

6 (3%)

aImipenem/Cilastatin (500mg/500mg) + Relebactam (250mg), IV every 6 hours
b Imipenem/Cilastatin (500mg/500mg) + Placebo, IV every 6 hours.
c Anemia includes anemia and hemoglobin decreased.
d Infusion site reactions include infusion site phlebitis, infusion site erythema and infusion site pain.
e Central nervous system adverse reactions include agitation, apathy, confusional states, delirium, disorientation, slow speech, and somnolence
f Hypertension includes hypertension and blood pressure increased.

RECARBRIO Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar among men and women.
  • Race: The majority of patients were White. The number of patients in other races was limited. Therefore, differences in the occurrence of side effects could not be determined.
  • Age: The occurrence of side effects was similar among patients younger and older than 65 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The tables below summarize the most common adverse reactions, diarrhea and nausea, by sex and age subgroup. Race subgroups were not tested because of the population was predominantly White.

Table 3. Adverse Events Reported in ≥ 1% of Subjects in Trial 1 and Trial 2 by Treatment Group and Sex

 Adverse Event

RECARBRIOa
N=216
n (%)

Imipenem/Cilastatin plus placebob
N=214
n (%)

 

Men

Women

Women

Men

Diarrhea

8 (3.7%)

4 (1.8%)

5 (2.3%)

4 (1.9%)

Nausea

5 (2.3%)

7 (3.2%)

6 (2.8%)

6 (2.8%)

aImipenem/Cilastatin (500mg/500mg) + Relebactam (250mg), IV every 6 hours.

bImipenem/Cilastatin (500mg/500mg) + Placebo, IV every 6 hours.

FDA Review

Table 4. Adverse Events Reported in ≥ 1% of Subjects in Trial 1 and Trial 2 by Treatment Group and Age Group

 Adverse Event

RECARBRIOa
N=216
n (%)

Imipenem/Cilastatin plus
placebo b
N=214
n (%)

 

< 65 years

> 65 years

< 65 years

> 65 years

Diarrhea

6 (2.7%)

6 (2.7%)

5 (2.3%)

4 (1.9%)

Nausea

10 (4.6%)

2 (0.9%)

11 (5.1%)

1 (0.5%)

aImipenem/Cilastatin (500mg/500mg) + Relebactam (250mg), IV every 6 hours.

bImipenem/Cilastatin (500mg/500mg) + Placebo, IV every 6 hours.

FDA Review

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

RECARBRIO was studied in two clinical trials (Trial 1/NCT01505634, Trial 2/NCT01506271) of 430 patients with cUTI or cIAI. The trials were conducted in Europe, South America, United Sates, Asia Pacific, Africa, and Mexico. 
The FDA primarily considered previous findings of the efficacy and safety of imipenem/cilastatin in the treatment of cIAI and cUTI as well as the evidence from the laboratory and animal studies showing the contribution of relebactam.

Figure 1 summarizes how many men and women were in the clinical trials used to evaluate safety.

Figure 1. Baseline Demographics by Sex (safety population)

Figure 1

FDA Review

Figure 2. Baseline Demographics by Race (safety population)

Baseline Demographics by Race (safety population)

*Other includes American Indian, or Alaska Native

FDA Review

Table 1. Demographics of Trials by Race (safety population)

Race

Number of Patients

Percentage of Patients

White

397

92%

Black or African American

3

1%

Asian

11

3%

American Indian or Alaska Native

2

Less than 1

Other

17

4%

FDA Review

Figure 3 summarizes the percentage of patients by age group in the clinical trials used to evaluate safety.

Figure 3. Baseline Demographics by Age (safety population)

Baseline Demographics by Age (safety population)

FDA Review

Who participated in the trials?

The table below summarizes demographics of patients in Trial 1 and Trial 2.

Table 5. Demographic Characteristics (safety population)

Demographic Parameters

 

RECARBRIOa
N= 216
n (%)

Imipenem/Cilastatin plus placebo
N=214
n (%)

Total
(N=430)
n (%)

Sex

Men

124 (57.4%)

122 (57.0%)

246 (57.2%)

Women

92 (42.6%)

92 (43.0%)

184 (42.8%)

Race

White

198 (91.7%)

199 (93.0%)

397 (92.3%)

 Black or African American

2 (0.9%)

1 (0.5%)

3 (0.7%)

Asian

4 (1.9%)

7 (3.3%)

11 (2.6%)

American Indian or Alaska Native

2 (0.9%)

0 (0.0%)

2 (0.5%)

 Other

10 (4.6%)

7 (3.3%)

17 (3.9%)

Age

Mean years (SD)

52.5 (18.7)

52.0 (18.7)

52.2 (18.7)

Median (years)

55

54

55

Min, max (years)

18, 90

18, 88

18, 90

Age Group

< 65 years

149 (69.0%)

150 (70.1%)

299 (69.5%)

≥ 65 years

67 (31.0%)

64 (29.9%)

131 (30.5%)

Ethnicity

Hispanic or Latino

15 (6.9%)

9 (4.2%)

24 (5.6%)

Not Hispanic or Latino

191 (88.4%)

192 (89.7%)

383 (89.1%)

Not reported/unknown

10 (4.6%)

13 (6.1%)

23 (5.3%)

Region

Africa

4 (1.9%)

2 (0.9%)

6 (1.4%)

Asia Pacific

4 (1.9%)

5 (2.3%)

9 (2.1%)

Europe

184 (85.2%)

190 (88.8%)

374 (87.0%)

Mexico

0

1 (0.5%)

1 (0.2%)

South America

15 (6.9%)

8 (3.7%)

23 (5.3%)

 United States

9 (4.2%)

8 (3.7%)

17 (4.0%)

aImipenem/Cilastatin (500mg/500mg) + Relebactam (250mg), IV every 6 hours.

FDA Review

How were the trials designed?

Trial 1 enrolled adult patients hospitalized with cUTI. Trial 2 enrolled adult patients hospitalized with cIAI that required surgery or drainage. In both trials, patients were assigned to either imipenem/cilastatin with varying doses of relebactam or imipenem/cilastatin with placebo intravenously, every 6 hours for 4 to 14 days.  Neither the patients nor the investigators knew which treatment was being given until after the trial was completed. 

The trials provided data primarily for evaluation of side effects.

How were the trials designed?

There were two randomized, active-control trials in adult patients. Trial 1 enrolled hospitalized patients with cUTI. Trial 2 enrolled adult patients hospitalized with cIAI that required surgery or drainage. In both trials, patients were randomly assigned to either imipenem /cilastatin with varying doses of relebactam, or imipenem/cilastatin with placebo intravenously every 6 hours for 4 to 14 days.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

Back to Drug Trials Snapshots

http://www.fda.gov/drugs/resources-information-approved-drugs/drug-trial-snapshot-recarbrio

DDT COA #000007: The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)

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Clinical Outcome Assessments (COA) Qualification Submissions
Office of Antimicrobial Products (OAP)
Division of Anti-Infective Products (DAIP)

DDT COA Number
DDT COA #000007

Instrument Name
The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)

Disease/Condition
Cystic Fibrosis (CF)

Concept of Interest
CF symptom severity

Context of Use
Adolescents (≥12 years) and adults with a chronic respiratory infection in stable patients and patients with an acute exacerbation

COA Type
PRO

Qualification Stage
In legacy process*

Requestor(s)
Evidera
The Cystic Fibrosis Foundation

Contact(s)
Robin Pokrzywinski

Date Accepted into CDER’s COA Qualification Program
October 30, 2013

*Under review prior to the passage of the 21st Century Cures Act

Back to Clinical Outcome Assessments (COA) Qualification Submission

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http://www.fda.gov/drugs/ddt-coa-000007-cystic-fibrosis-respiratory-symptom-diary-chronic-respiratory-infection-symptom-score

Arthritis Advisory Committee Roster

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Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees. More info (Posted 1/7/2011)

Current Number of Vacancies = 0

Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

http://www.fda.gov/advisory-committees/arthritis-advisory-committee/arthritis-advisory-committee-roster

Treating and Preventing Head Lice

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Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have head lice. While lice are a year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).

Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans.

An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.

Lice don’t fly or jump; they move by crawling. But because children play so closely together and often in large groups, lice can easily travel from child to child, especially when they touch heads during playing or talking.

Identifying and Treating Headlice

Head lice are blood-sucking insects about the size of a sesame seed and tan to grayish-white in color. They attach themselves to the skin on the head and lay eggs (nits) in the hair.

According to Brown, you can check for head lice or nits by parting the hair in several spots. You can use a magnifying glass and a bright light to help spot them. Because head lice can move fast it may be easier to spot the nits. Nits can look like dandruff, but you can identify them by picking up a strand of hair close to the scalp and pulling your fingernail across the area where you suspect a nit. Dandruff will come off easily, but nits will stay firmly attached to the hair, Brown explains.

FDA-approved treatments for head lice include both over-the-counter (OTC) and prescription drugs, such as Nix and Rid, in the form of shampoos, creams and lotions. “Many head lice products are not for use in children under the age of 2, so read the label carefully before using a product to make sure it is safe to use on your child,” Brown says.

Although OTC drugs are available for treatment of head lice, Brown says your health care professional may prescribe drugs approved by the FDA, such as Ulesfia (approved in 2009), Natroba (approved in 2011) or Sklice (approved in 2012).

How to Help Prevent Getting Head Lice

  • Teach children to avoid head-to-head contact during play and other activities at home, school, and elsewhere (sports activities, playgrounds, slumber parties, and camps).
  • Teach children not to share clothing and supplies, such as hats, scarves, helmets, sports uniforms, towels, combs, brushes, bandanas, hair ties, and headphones.
  • Disinfest combs and brushes used by a person with head lice by soaking them in hot water (at least 130°F) for 5–10 minutes.
  • Do not lie on beds, couches, pillows, carpets, or stuffed animals that have recently been in contact with a person with head lice.
  • Clean items that have been in contact with the head of a person with lice in the 48 hours before treatment. Machine wash and dry clothing, bed linens, and other items using hot water (130°F) and a high heat drying cycle. Clothing and items that are not washable can be dry-cleaned or sealed in a plastic bag and stored for two weeks.
  • Vacuum the floor and furniture, particularly where the person with lice sat or lay. Head lice survive less than one or two days if they fall off the scalp and cannot feed.
  • Do not use insecticide sprays or fogs; they are not necessary to control head lice and can be toxic if inhaled or absorbed through the skin.
  • After finishing treatment with lice medication, check everyone in your family for lice after one week. If live lice are found, contact your health care professional.

Steps for Safe Use of Treatment Products

Follow these steps to use any head lice treatment safely and appropriately:

  • After rinsing the product from the hair and scalp, use a fine-toothed comb or special “nit comb” to remove dead lice and nits.
  • Apply the product only to the scalp and the hair attached to the scalp—not to other body hair.
  • Before treating young children, talk with the child’s doctor or your pharmacist for recommended treatments based on a child’s age and weight.
  • Use medication exactly as directed on the label and never more often than directed unless advised by your health care professional.
  • Use treatments on children only under the direct supervision of an adult.

How to Help Prevent Getting Head Lice source: Centers for Disease Control and Prevention

August 31, 2017

   

http://www.fda.gov/consumers/consumer-updates/treating-and-preventing-head-lice

FDA approves first therapy for rare joint tumor

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For Immediate Release:
August 02, 2019

Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

“TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement. The tumor can significantly affect a patient’s quality of life and cause severe disability,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Surgery is the primary treatment option, but some patients are not eligible for surgery, and tumors can recur, even after the procedure. Today’s approval is the first FDA-approved therapy to treat this rare disease.”

TGCT is a rare tumor that affects the synovium (thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths (layer of membrane that covers tendons, which are fibrous tissue that connect muscle to bone). The tumor is rarely malignant but causes the synovium and tendon sheaths to thicken and overgrow, causing damage to surrounding tissue.

The approval of Turalio was based on the results of a multi-center international clinical trial of 120 patients, 59 of whom received placebo. The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. The clinical trial demonstrated a statistically significant improvement in ORR in patients who received Turalio, with an ORR of 38%, compared to no responses in patients who received placebo. The complete response rate was 15% and the partial response rate was 23%. A total of 22 out of 23 responders who had been followed for a minimum of six months following the initial response maintained their response for six or more months, and a total of 13 out of 13 responders who had been followed for a minimum of 12 months following the initial response maintained their response for 12 or more months.

The prescribing information for Turalio includes a Boxed Warning to advise health care professionals and patients about the risk of serious and potentially fatal liver injury. Health care professionals should monitor liver tests prior to beginning treatment and at specified intervals during treatment. If liver tests become abnormal, Turalio may need to be withheld, the dose reduced, or permanently discontinued, depending on the severity of the liver injury. Turalio is available only through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program.

Common side effects for patients taking Turalio were increased lactate dehydrogenase (proteins that helps produce energy in the body), increased aspartate aminotransferase (enzymes that are mostly in the liver but also in muscles), loss of hair color, increased alanine aminotransferase (enzymes that are primarily in the liver and kidney) and increased cholesterol. Additional side effects included neutropenia (low level of white blood cells that help the immune system defend against disease and infection), increased alkaline phosphatase (enzymes that are mostly in the cells of bone and the liver), decreased lymphocytes (white blood cells that help the immune system defend against disease and infection), eye edema (swelling around the eyes), decreased hemoglobin (protein in red blood cells that carry oxygen), rash, dysgeusia (altered sense of taste) and decreased phosphate (electrolytes that help with energy).

The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Turalio. Women who are pregnant or breastfeeding should not take Turalio because it may cause harm to a developing fetus or newborn baby. Turalio must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

The FDA granted this application Breakthrough Therapy designation and Priority Review designation. Turalio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Turalio to Daiichi Sankyo.
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###


Inquiries

Consumer:
888-INFO-FDA

Related Information

http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-joint-tumor

Warning Letters 2019

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These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.     

If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to: 

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request can be found on the FDA Freedom of Information Page.

Office of Prescription Drug Promotion

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Office of Compliance/Immediate Office 

American Sales Company

diphenhydramine hydrochloride and zinc acetate, NDC 41520-090; failure to address the listing deficiencies detailed in FDA’s letter to your company on March 19, 2019

7/11/2019

Yuyao Jessie Commodity Co., Ltd.

Mouth Fresh, NDC 51414-501/ failure to fulfill listing obligations 4/18/2019

ABC Compounding Co., Inc. 

 Santi Wash Antiseptic Hand Wash, NDC 62257-275/ failure to fulfill listing obligations 4/18/2019

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Office of Manufacturing Quality

Indoco Remedies Limited

CGMP/Finished Pharmaceuticals/Adulterated 7/9/2019

Strides Pharma Limited

CGMP/Finished Pharmaceuticals/Adulterated 7/1/2019

Aurobindo Pharma Limited

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 6/20/2019

Rxhomeo Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 6/13/2019

Xi’an Livingbond Nonwoven Products Corp., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 6/10/2019

Glint Cosmetics Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 5/31/2019

Vida International, Inc.

CGMP/Finished Pharmaceuticals/Adulterated 5/29/2019

Petra Hygienic Systems International, LLC

CGMP/Finished Pharmaceuticals/Adulterated 5/7/2019

Centurion Laboratories Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 5/4/2019

Laboratoires Clarins

CGMP/Finished Pharmaceuticals/Adulterated 4/23/2019

Luen Fook Medicine Sdn., Bhd.

CGMP/Finished Pharmaceuticals/Adulterated 4/4/2019

B. Jain Pharmaceuticals Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 3/21/2019

Dong Yuan Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

3/18/2019

Jubilant Life Sciences

CGMP/Finished Pharmaceuticals/Adulterated

3/6/2019

Hospira Healthcare India Pvt. Ltd

CGMP/Finished Pharmaceuticals/Adulterated 3/4/2019

Anicare Pharmaceuticals Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 2/28/2019

Proandre SL

CGMP/Finished Pharmaceuticals/Adulterated

2/13/2019

Vipor Chemicals Private Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

1/29/2019

Hangzhou Sunking Nonwovens Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

1/29/2019

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Office of Scientific Investigations

Lymol Medical Corp

Postmarket Requirements (PMRs) 1/8/2019

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Office of Unapproved Drugs and Labeling Compliance

Curaleaf, Inc

Unapproved New Drugs/Misbranded 7/22/2019

Cali Botanicals, LLC

Unapproved New Drugs/Misbranded 6/11/2019

Kratom NC

Unapproved New Drugs/Misbranded 5/16/2019

/Advanced Spine and Pain, LLC (d/b/a Relievus)/

Unapproved New Drugs/Misbranded 3/28/2019

Nutra Pure LLC

Unapproved New Drugs/Misbranded 3/28/2019

Nutra Pharma Corp.

Unapproved New Drugs/Misbranded

3/19/2019

 Aidaccess

Unapproved New Drugs/Misbranded 3/8/2019

Rablon

Unapproved New Drugs/Misbranded 3/8/2019

Office of Drug Security, Integrity and Recalls

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http://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/warning-letters-2019

CDER Small Business & Industry Assistance (SBIA)

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http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication – Due to an Increased Risk of Blood Clots and Death with Higher Dose

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[Posted 07/26/2019]

AUDIENCE: Patient, Health Professional, Pharmacy, Gastroenterology, Rheumatology

ISSUE: FDA has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine.

BACKGROUND: Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and ulcerative colitis. Tofacitinib was first approved in 2012 to treat adult patients with RA who did not respond well to the medicine methotrexate. When FDA first approved tofacitinib in 2012, FDA required a post-marketing clinical trial in patients with RA on background methotrexate, to evaluate the risk of heart-related events, cancer, and infections. The trial is studying two different doses of tofacitinib (5 mg twice daily, which is the currently approved dose for RA, and a higher, 10 mg twice daily dosage) in comparison to a TNF blocker. In RA, the body attacks its own joints, causing pain, swelling, and loss of function. An interim analysis of the trial’s results found an increased occurrence of blood clots and of death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF blocker. In 2017, we approved the medicine to treat patients with a second condition that causes joint pain and swelling, PsA, who did not respond well to methotrexate or other similar medicines. In 2018, we approved tofacitinib to treat ulcerative colitis, which is a chronic, inflammatory disease affecting the colon.

RECOMMENDATION:

Patients should tell your health care professionals if you have a history of blood clots or heart problems, and talk to them about any questions or concerns. Stop taking tofacitinib and seek emergency medical attention right away if you experience any unusual symptoms, including those that may signal a blood clot such as:

  • Sudden shortness of breath
  • Chest pain that worsens with breathing
  • Swelling of a leg or arm
  • Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm

Do not stop taking tofacitinib without first talking to your health care professional, as doing so can worsen your condition.

Healthcare professionals should discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis. Counsel patients about the risks and advise them to seek medical attention immediately if they experience any unusual symptoms, including those of thrombosis listed above. Reserve tofacitinib to treat ulcerative colitis for patients who have failed or do not tolerate tumor necrosis factor (TNF) blockers. Avoid tofacitinib in patients who may have a higher risk of thrombosis. When treating ulcerative colitis, use tofacitinib at the lowest effective dose and limit the use of the 10 mg twice daily dosage to the shortest duration needed (See Additional Information for Health Care Professionals for more recommendations).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178

[07/26/2019 – Drug Safety Communication – FDA] 

http://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-due-increased-risk-blood-clots-and-death

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