[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Pages 41135-41136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Xellia Pharmaceuticals USA, LLC; Withdrawal of Approval of an 
Abbreviated New Drug Application 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 the approval of an 
abbreviated new drug application (ANDA) for bacitracin for injection, 
50,000 units/vial (ANDA 203177), held by Xellia Pharmaceuticals USA, 
LLC (Xellia). Xellia has requested withdrawal of approval of this 
application and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of July 11, 2022.

FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 301-
402-9674, <a href="/cdn-cgi/l/email-protection#6c3f19020b06030302422f04052c0a080d4204041f420b031a"><span class="__cf_email__" data-cfemail="56052338313c39393878153e3f16303237783e3e2578313920">[email protected]</span></a>.

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. 
Health care 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 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 a letter dated June 14, 2021, Xellia requested that FDA withdraw 
approval of ANDA 203177 under Sec.  314.150(d) and waived its 
opportunity for a hearing. Therefore, for the reasons discussed above, 
which the applicant does not dispute in its letter requesting 
withdrawal of approval under Sec.  314.150(d), FDA's approval of ANDA 
203177 and all amendments and supplements thereto, is withdrawn (see 
DATES). Distribution of Xellia'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,

[[Page 41136]]

Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))).

    Dated: July 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14680 Filed 7-8-22; 8:45 am]
BILLING CODE 4164-01-P


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