Notice2022-00832
Determination That PEPCID (Famotidine) Tablet, 20 Milligrams and 40 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
January 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Administration (FDA or Agency) has determined that PEPCID (famotidine) tablet, 20 milligrams (mg) and 40 mg, was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 87 Issue 11 (Tuesday, January 18, 2022)</title>
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[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Notices]
[Pages 2616-2617]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00832]
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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40 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or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.
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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mg, was not withdrawn from sale for reasons of safety or effectiveness.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, <a href="/cdn-cgi/l/email-protection#384b4c595b41165359565d785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="17646376746e397c76797257717376397f7f6439707861">[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 (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
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