[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Page 47147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15454]
[[Page 47147]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2796]
Bristol Myers Products Inc.; Withdrawal of Approval of a New Drug
Application for BUFFERIN (Aspirin) Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of a new drug application (NDA) for BUFFERIN
(aspirin) tablets. The basis for the withdrawal is that the holder of
the NDA has repeatedly failed to file required annual reports for this
NDA.
DATES: Approval is withdrawn as of July 21, 2023.
FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035, [email protected].
SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec. 314.81
(21 CFR 314.81). In the Federal Register of November 23, 2022 (87 FR
71652), FDA published a notice offering an opportunity for a hearing
(NOOH) on a proposal to withdraw approval of NDA 006499 for BUFFERIN
(aspirin) tablets, and all amendments and supplements thereto, on the
grounds that the holder of NDA 006499 has repeatedly failed to file
required annual reports for this NDA.
NDA 006499 for BUFFERIN (aspirin) tablets became effective on June
30, 1948. The holder of NDA 006499 is currently identified in FDA's
records as Bristol Myers Products Inc. The Agency has received
conflicting information regarding the identity of the current NDA
holder. However, to change the holder of record, information specified
in Sec. 314.72 (21 CFR 314.72) must be provided to the Agency. Since
the time that the holder of record was identified as Bristol Myers
Products Inc., the Agency has not received change of application
ownership information that would satisfy the requirements of Sec.
314.72. The Agency therefore identified Bristol Myers Products Inc. as
the NDA holder of record in the NOOH published in the Federal Register
of November 23, 2022, but if another entity held NDA 006499, the Agency
also provided notice to that entity through the same NOOH.
Bristol Myers Products Inc. did not respond to the NOOH and nor did
any other party. Failure of the NDA holder to file a written notice of
participation and request for hearing pursuant to Sec. 314.200 (21 CFR
314.200) constitutes an election by the holder of the NDA not to make
use of the opportunity for a hearing concerning the proposal to
withdraw approval of its NDA and a waiver of any contentions concerning
the legal status of the drug product.
FDA finds that the holder of NDA 006499 has repeatedly failed to
submit reports required by Sec. 314.81. In addition, under Sec.
314.200, FDA finds that the holder of the NDA 006499 has waived the
opportunity for a hearing concerning the withdrawal of approval of this
NDA as well as any contentions concerning the legal status of the drug
product covered by this NDA. Therefore, under these findings, approval
of NDA 006499 and all amendments and supplements thereto is hereby
withdrawn as of July 21, 2023.
Based on information available to the Agency, it appears that the
product covered by NDA 006499 has not been marketed for many years and
another buffered aspirin drug product, using the same trade name
``BUFFERIN'' but with a different formulation, is currently being
marketed as an over the counter (OTC) monograph drug. The marketing of
this current ``BUFFERIN'' product is subject to the requirements for
legal marketing of OTC monograph drugs under section 505G of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h).
Withdrawal of the approval of NDA 006499 does not impact
nonprescription aspirin products that are legally marketed without an
approved application as OTC monograph drugs in accordance with section
505G of the FD&C Act, including conforming to applicable conditions of
use specified in OTC Monograph M013: Internal Analgesic, Antipyretic,
and Antirheumatic Drug Products for Over-the-Counter Human Use (See OTC
Monographs@FDA web page available at https://www.accessdata.fda.gov/scripts/cder/omuf/?event=reqOrders).
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15454 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P