Notice2022-19995
Determination That Bacitracin for Injection, 10,000 Units/Vial and 50,000 Units/Vial, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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(FDA or Agency) has determined that bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 87 Issue 178 (Thursday, September 15, 2022)</title>
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56680-56681]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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and 50,000 Units/Vial, Was Withdrawn From Sale for Reasons of Safety or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units/vial, was withdrawn from sale for reasons of safety or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, <a href="/cdn-cgi/l/email-protection#c596b0aba2afaaaaabeb86adac85a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="3e6d4b505954515150107d56577e585a5f1056564d10595148">[email protected]</span></a>.
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
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