[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Notices]
[Pages 2616-2617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00832]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0885]


Determination That PEPCID (Famotidine) Tablet, 20 Milligrams and 
40 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that PEPCID (famotidine) tablet, 20 milligrams (mg) and 40 
mg, was not withdrawn from sale for reasons of safety or effectiveness. 
This determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring,

[[Page 2617]]

MD 20993-0002, 301-796-8363, [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 (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.
    PEPCID (famotidine) tablet, 20 mg and 40 mg, is the subject of NDA 
019462, held by Valeant Pharmaceuticals North America LLC, and 
initially approved on October 15, 1986. PEPCID is indicated in adult 
and pediatric patients 40 kilograms and greater for the treatment of 
active duodenal ulcer (DU), active gastric ulcer, symptomatic 
nonerosive gastroesophageal reflux disease (GERD), erosive esophagitis 
due to GERD, diagnosed by biopsy. PEPCID is indicated in adults for the 
treatment of pathological hypersecretory conditions (e.g., Zollinger-
Ellison syndrome, multiple endocrine neoplasias) and reduction of the 
risk of DU recurrence.
    PEPCID (famotidine) tablet, 20 mg and 40 mg, is currently listed in 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Zydus Pharmaceuticals (USA) Inc. submitted a citizen petition dated 
August 3, 2021 (Docket No. FDA-2021-P-0885), under 21 CFR 10.30, 
requesting that the Agency determine whether PEPCID (famotidine) 
tablet, 20 mg and 40 mg, was withdrawn from sale for reasons of safety 
or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that PEPCID (famotidine) tablet, 20 mg and 40 mg, 
was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
PEPCID (famotidine) tablet, 20 mg and 40 mg, was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of PEPCID (famotidine) tablet, 20 mg 
and 40 mg, from sale. We have also independently evaluated relevant 
literature and data for possible postmarketing adverse events. We have 
found no information that would indicate that this drug product was 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PEPCID (famotidine) 
tablet, 20 mg and 40 mg, in the ``Discontinued Drug Product List'' 
section of the Orange Book. The ``Discontinued Drug Product List'' 
delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also be approved by the Agency as long as they 
meet all other legal and regulatory requirements for the approval of 
ANDAs. If FDA determines that labeling for this drug product should be 
revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: January 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00832 Filed 1-14-22; 8:45 am]
BILLING CODE 4164-01-P


