[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14127-14128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2143]


Withdrawal of Approval of Five Abbreviated New Drug Applications 
for Bacitracin for Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is withdrawing approval of five 
abbreviated new drug applications (ANDAs) from multiple holders. Akorn 
Inc. (Akorn), Mylan ASI LLC (Mylan), Pfizer Inc. (Pfizer), X-GEN 
Pharmaceuticals, Inc. (X-GEN), and Fresenius Kabi USA, LLC (Fresenius) 
have requested withdrawal of approval of their respective applications 
and have waived their opportunity for a hearing.

DATES: Approval is withdrawn as of March 12, 2021.

FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3600, 
[email protected].

SUPPLEMENTARY INFORMATION: On January 31, 2020, FDA requested that all 
application holders of bacitracin for injection voluntarily request 
withdrawal of approval of their applications under Sec.  314.150(d) (21 
CFR 314.150(d)). Bacitracin for injection is an antibiotic for 
intramuscular administration, the use of which is limited to the 
treatment of infants with pneumonia and empyema caused by staphylococci 
shown to be susceptible to the drug. Bacitracin for injection poses 
serious risks, including nephrotoxicity and anaphylactic reactions. 
Healthcare professionals generally no longer use bacitracin for 
injection to treat infants with pneumonia and empyema because other 
effective FDA-approved treatments are available that do not have these 
risks.
    In April 2019, FDA's Antimicrobial Drugs Advisory Committee met and 
discussed the safety and effectiveness of bacitracin for injection. The 
advisory committee voted almost unanimously, with one abstention, that 
the benefits of bacitracin for intramuscular injection do not outweigh 
its risks, including nephrotoxicity and anaphylactic reactions, for the 
drug's only approved indication. Based on FDA's review of

[[Page 14128]]

currently available data and information, the Agency believes that the 
potential problems associated with bacitracin for injection are 
sufficiently serious that the drug should be removed from the market.
    In separate letters dated February 5, 2020, Akorn and Mylan 
requested that FDA withdraw approval of ANDAs 206719 and 090211 under 
Sec.  314.150(d). Akorn and Mylan each waived their opportunity for a 
hearing. Additionally, in separate letters dated February 7, 2020, 
Pfizer, X-GEN, and Fresenius requested that FDA withdraw approval of 
ANDAs 060733, 064153, and 065116, respectively, under Sec.  314.150(d). 
Pfizer, X-GEN, and Fresenius also waived their opportunity for a 
hearing. Additionally, Akorn stated that it has never launched this 
product since its approval; X-GEN stated that it no longer manufactures 
bacitracin for injection under ANDA 064153; and Mylan stated that its 
product has not been in commercial distribution since 2012.
    Therefore, for the reasons discussed above, which the applicants do 
not dispute in their letters requesting withdrawal of approval under 
Sec.  314.150(d), FDA's approval of ANDAs 206719, 090211, 060733, 
064153, 065116, and all amendments and supplements thereto, is 
withdrawn (see DATES). Distribution of Akorn's bacitracin for injection 
(50,000 units/vial), Mylan's bacitracin for injection (50,000 units/
vial), Pfizer's bacitracin for injection (10,000 units/vial and 50,000 
units/vial), X-GEN's bacitracin for injection (50,000 units/vial), or 
Fresenius's bacitracin for injection (50,000 units/vial) into 
interstate commerce without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))).

    Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05105 Filed 3-11-21; 8:45 am]
BILLING CODE 4164-01-P