[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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DATES: Approval is withdrawn as of July 21, 2023.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