[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56680-56681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Determination That Bacitracin for Injection, 10,000 Units/Vial 
and 50,000 Units/Vial, Was Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that bacitracin for injection, 10,000 units/vial and 50,000 
units/vial, was withdrawn from sale for reasons of safety or 
effectiveness. The Agency will not accept or approve abbreviated new 
drug applications (ANDAs) for bacitracin for injection.

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, 240-
402-9674, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of 
all approved drugs. FDA publishes this list as part of the ``Approved 
Drug Products With Therapeutic Equivalence Evaluations,'' which is 
known generally as the ``Orange Book.'' Under FDA regulations, drugs 
are removed from the list if the Agency withdraws or suspends approval 
of the drug's NDA or ANDA for reasons of safety or effectiveness or if 
FDA determines that the listed drug was withdrawn from sale for reasons 
of safety or effectiveness (Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    Bacitracin for injection, 10,000 units/vial and 50,000 units/vial, 
is the subject of ANDA 060733 (originally NDA 6-483), held by Pharmacia 
and Upjohn Company (a subsidiary of Pfizer Inc.), and was initially 
approved on July 29, 1948. 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

[[Page 56681]]

to the drug. However, in 1984, the Anti-Infective Drugs Advisory 
Committee concluded that intramuscular administration of bacitracin was 
not safe and effective. In addition, in April 2019, FDA's Antimicrobial 
Drugs Advisory Committee advised that the benefits of bacitracin for 
injection do not outweigh its risks for the drug's only approved 
indication.
    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. Out of concern about these 
risks, 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)). Two 
approved applications for bacitracin for injection had been withdrawn 
prior to January 31, 2020 (see 61 FR 40649, August 5, 1996, and 57 FR 
6228, February 21, 1992) and therefore FDA did not need to request 
their withdrawal. In a letter dated February 7, 2020, Pfizer requested 
withdrawal of approval of ANDA 060733 (originally NDA 6-483) for 
bacitracin for injection under Sec.  314.150(d) and waived its 
opportunity for a hearing. In separate letters dated February 5, 2020, 
Akorn Inc. and Mylan ASI LLC requested that FDA withdraw approval of 
ANDAs 206719 and 090211, respectively, under Sec.  314.150(d) and 
waived their opportunity for a hearing. Additionally, in separate 
letters dated February 7, 2020, X-GEN Pharmaceuticals, Inc. and 
Fresenius Kabi USA, LLC requested that FDA withdraw approval of ANDAs 
064153 and 065116, respectively, under Sec.  314.150(d) and waived 
their opportunity for a hearing. In the Federal Register of March 12, 
2021 (86 FR 14127), FDA announced that it was withdrawing approval of 
ANDAs 060733 (originally NDA 6-483), 206719, 090211, 064153, and 
065116, and all amendments and supplements thereto, effective March 12, 
2021.
    In a letter dated June 14, 2021, the only remaining application 
holder, Xellia Pharmaceuticals USA, LLC, requested that FDA withdraw 
approval of ANDA 203177 under Sec.  314.150(d) and waived its 
opportunity for a hearing. In the Federal Register of July 11, 2022 (87 
FR 41135), FDA announced that it was withdrawing approval of ANDA 
203177, and all supplements thereto, effective July 11, 2022. 
Accordingly, the Agency has withdrawn approval of all ANDAs for 
bacitracin for injection.
    After reviewing Agency records and based on the information we have 
at this time, FDA has determined under Sec.  314.161 that bacitracin 
for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn 
for reasons of safety or effectiveness. We have reviewed our files for 
records concerning the withdrawal of bacitracin for injection from 
sale. We have also independently evaluated relevant literature and data 
for possible postmarketing adverse events. Based on a thorough 
evaluation of this information, including information presented to 
FDA's Antimicrobial Drugs Advisory Committee and the recommendations of 
that committee, and an evaluation of the latest version of the drug 
product's labeling, we have determined that bacitracin for injection, 
10,000 units/vial and 50,000 units/vial, would not be considered safe 
and effective if it were introduced to the market today in the absence 
of new preclinical or clinical studies to address safety or 
effectiveness concerns identified during our review.
    Accordingly, the Agency will remove bacitracin for injection, 
10,000 units/vial and 50,000 units/vial, from the list of drug products 
published in the Orange Book. FDA will not accept or approve ANDAs that 
refer to this drug product.

    Dated: September 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19995 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P