Withdrawal of Approval of Five Abbreviated New Drug Applications for Bacitracin for Injection, 14127-14128 [2021-05105]
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
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Dated: March 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05202 Filed 3–11–21; 8:45 am]
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14127
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.
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DATES: Approval is withdrawn as of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,
Sungjoon.Chi@fda.hhs.gov.
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
§ 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
SUMMARY:
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12MRN1
14128
Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
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 § 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 § 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
§ 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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0279]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Marketing; Administrative Procedures,
Policies, and Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
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2011–N–0279 for ‘‘Agency Information
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
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