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

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

Israel Allows Visit After Rep. Rashida Tlaib Agrees To Restrictions

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U.S. Rep. Rashida Tlaib, D-Mich., speaks to constituents in Wixom, Mich., on Thursday. Paul Sancya/AP hide caption

toggle caption

Paul Sancya/AP

U.S. Rep. Rashida Tlaib, D-Mich., speaks to constituents in Wixom, Mich., on Thursday.

Paul Sancya/AP

Updated at 6:45 a.m. ET

Israel’s interior ministry announced Friday that it would allow Rep. Rashida Tlaib, D-Mich., to enter the country as a private citizen to visit her aging grandmother, reversing an earlier decision to bar her amid pressure from President Trump.

The about-face regarding Tlaib, whose parents are Palestinian immigrants to the U.S. and who has close relatives in the West Bank, came hours after Israel banned her and fellow Muslim Rep. Ilhan Omar, D-Minn., apparently in response to pressure from Trump, who tweeted that the two hated “Israel & all Jewish people” and that Israel “would show great weakness” by letting them visit.

On Friday, however, Israel’s interior ministry said Minister Aryeh Deri had decided to allow Tlaib to conduct a “humanitarian visit” to her 90-year-old grandmother. According to the statement, Tlaib sent a letter to Deri accepting conditions and limits on her visit and promising not to advance boycotts against Israel while she is there.

There was no word on whether Israel had changed its position on Omar, a Somali-born American. She had been scheduled to arrive on Saturday in Israel, where she and Tlaib planned to tour the West Bank and visit the Al-Aqsa Mosque in Jerusalem.

Tlaib and Omar were to have traveled under the auspices of the Palestinian Initiative for the Promotion of Global Dialogue and Democracy, or MIFTAH, a Ramallah-based nongovernmental organization promoting an independent Palestinian state.

Earlier, Israeli Prime Minister Benjamin Netanyahu said in a lengthy statement that the trip sought to “harm Israel and increase incitement against it.” Israel initially barred the congresswomen’s visit on the basis of a law that allows authorities to ban advocates of a Palestinian-led movement to boycott Israel.

The move elicited a strong backlash from individuals in both parties. Democratic House Speaker Nancy Pelosi called the move “deeply disappointing.” Florida Republican Sen. Marco Rubio tweeted that while he disagreed “100% with Rep. Tlaib & Omar on #Israel” denying them entry to Israel “is a mistake.”

Even AIPAC, the powerful pro-Israel lobby group, tweeted that “every member of Congress should be able to visit and experience our democratic ally Israel firsthand.”

Provided By NPR

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

If Our Economy Is So Great, Why Did The Fed Vote To Juice It?

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WASHINGTON, DC - JULY 31: Federal Reserve Board Chairman Jerome Powell speaks during a news conference after the attending the Board's two-day meeting on July 31, 2019 in Washington, DC. Powell announced that the Fed agreed to cut interest rates by a quarter of a point, which is the first rate cut since 2008. (Photo by Mark Wilson/Getty Images)
Mark Wilson/Getty Images
WASHINGTON, DC - JULY 31: Federal Reserve Board Chairman Jerome Powell speaks during a news conference after the attending the Board's two-day meeting on July 31, 2019 in Washington, DC. Powell announced that the Fed agreed to cut interest rates by a quarter of a point, which is the first rate cut since 2008. (Photo by Mark Wilson/Getty Images)

Mark Wilson/Getty Images

Editor’s note: This is an excerpt of Planet Money’s newsletter. You can sign up here.

Last week, policymakers at the Federal Reserve voted to bring interest rates down. Down! That’s despite a decade of economic growth, record low unemployment, solid corporate profits, and a good stock market. And it’s despite the fact the federal government has already been juicing the economy with big spending and tax cuts. In the old days, the Fed would be worried this would all make the price of everything explode (inflation), and they would be voting to *increase* rates to slow things down. But, no. They’re putting their foot on the accelerator. Fed Chairman Jerome Powell, at a press conference, explained, “weak global growth, trade policy uncertainty, and muted inflation have prompted [us] to adjust [our] assessment of the appropriate path of interest rates.”

The Fed’s decision has gotten a lot of attention (including this Indicator throwdown episode). But, we’ve been wondering, maybe the correct reaction should just be the shrug emoji ¯\_(ツ)_/¯.

Fed Up With Myths

Former Fed Chairman Ben Bernanke, shortly after leaving the helm of the Fed, wrote that he was pretty exasperated by the general public’s failure to grasp just how limited the Fed’s power is. Bernanke wrote: “If you asked the person in the street, ‘Why are interest rates so low?’, he or she would likely answer that the Fed is keeping them low. That’s true only in a very narrow sense.”

Translation: “We’re not superheroes here you know. We don’t have the power over the economy that you think we do.”

The main way the Fed influences interest rates is very narrow, usually through a policy lever known as the federal funds rate. It’s the rate banks charge each other to borrow money overnight. By making it cheaper for banks to borrow, it makes it cheaper for businesses and households to borrow. That is the traditional way the Fed has tried to boost the economy. It injects more money into the system.

The federal funds rate is an important interest rate, and it influences other interest rates — on mortgages, business loans, credit cards, etc — in the short term, but the Fed’s power over interest rates in general is very limited. The market ultimately determines real interest rates, not the Fed.

Interest-ing

To understand why interest rates are so low, it’s helpful to think like a central banker. When they make their decisions, they have a theoretical interest rate in mind. In typical central banker fashion, it has a bunch of confusing names that make your eyes glaze over: the equilibrium real interest rate, the Wicksellian interest rate, r-star, or the natural rate of interest. Central bankers like Jerome Powell have been increasingly calling it the “neutral rate,” so we’ll go with that.

The neutral rate is a theoretical resting place for interest rates. And the Fed doesn’t control it. Putting a number on it is a guess, or a moving target. It’s basically the interest rate in the economy’s sweet spot. It’s where the cost of borrowing money makes everything hum nicely. Basically everyone is employed if they want to be. All factories and machinery and technology are put to use. And the price of everything is pretty stable (not a lot of inflation). Not too hot. Not too cold. It’s the natural or neutral place to be.

This theoretical rate, like the real-world interest rates it represents, is ultimately set by the markets for money coming together. On one side, is all our savings. Our bank accounts, pension funds, and so on. That’s the supply of money for the stuff (capital) that grows our economy. On the other side, is that stuff, aka investment: factories, houses, laboratories, rocket ships, office chairs. That’s the demand for money. It’s a gazillion buyers and sellers all coming together to agree on the price of borrowing money.

The issue the Fed — and all of us, really — have been facing is that the neutral rate has been falling and falling and falling, since even before the financial crisis. That’s why the Fed is finding itself having to lower the interest rates under its influence now — even this far into an economic expansion. The fact that the neutral rate is so low is a reflection of a fundamental economic issue: there’s a big supply of savings floating out there, but there’s nowhere near the demand for investment. And that lack of investment is bad news for economic growth.

Where Is The Investment?

The Trump Administration sold the Tax Cuts and Jobs Act as a solution to the problem of lackluster investment. In our first Planet Money newsletter, we interviewed Kevin Hassett, who was then one of Trump’s chief economic advisers. He argued that cutting the tax rate on corporations would result in an investment boom. But, as the Fed acknowledged in a statement justifying its actions last week, the growth of investment over the last year has been “soft.”

Investment is a big deal because it gives us more machines and tools and structures that make workers better at their jobs — it increases productivity — and that is key to better wages, economic growth, and ultimately an improving standard of living.

It’s possible investment doesn’t look great because the escalating trade war is scaring businesses away from investing. But this problem of lackluster investment and productivity growth has been with us for decades now — and the Fed has proven that no matter how cheap it makes it to borrow money, investment and productivity remain disappointing. The economy may look good on some levels, but it’s still missing key ingredients that would make it look way better.

The Fed can grease the wheels of the economy with cheaper credit, and it can help guide it in a better direction, but it can’t fix the engine. So when the Fed cut the federal funds rate by a tiny amount, that’s why our reaction was basically ¯\_(ツ)_/¯. It’s not going to fundamentally fix intractable problems like low investment and productivity growth.

The fall of the neutral rate is a big deal, especially because with rates so low, the Fed currently might not have enough room to cut for when the next recession hits. Why after a decade of economic growth, with deficit spending and corporate tax cuts, and with the Fed keeping its foot on the accelerator, are we not seeing more growth?

Next week in Planet Money‘s newsletter: we dive into a theory that tries to explain it. You can sign up here.

Provided By NPR

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

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