Notice2022-07391
Determination That PEPCID (Famotidine) for Oral Suspension, 40 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID (famotidine) for oral suspension, 40 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PEPCID (famotidine) for oral suspension, 40 mg/5 mL, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 87 Issue 67 (Thursday, April 7, 2022)</title>
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[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20419-20420]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07391]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-P-1097 and FDA-2021-P-1111]
Determination That PEPCID (Famotidine) for Oral Suspension, 40
Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of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, Agency, or we) has
determined that PEPCID (famotidine) for oral suspension, 40 milligrams
(mg)/5 milliliters (mL), was not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for PEPCID (famotidine) for
oral suspension, 40 mg/5 mL, if all other legal and regulatory
requirements are met.
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, MD 20993-0002, 301-796-8363,
<a href="/cdn-cgi/l/email-protection#b7e4c3d6d4ce99fcd6d9d2f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="44173025273d6a0f252a21042220256a2c2c376a232b32">[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
[[Page 20420]]
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) for oral suspension, 40 mg/5 mL, is the subject
of NDA 019527, held by Bausch Health US, LLC, and initially approved on
February 2, 1987. PEPCID is indicated in adults 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; treatment of pathological
hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple
endocrine neoplasias); and reduction of the risk of DU recurrence.
PEPCID is indicated in pediatric patients 1 year of age and older for
the treatment of peptic ulcer, and GERD with or without esophagitis and
ulcerations. PEPCID is indicated in pediatric patients from birth to
less than 1 year of age for the treatment of GERD.
In a letter received on January 11, 2019, the applicant notified
FDA that PEPCID (famotidine) for oral suspension, 40 mg/5 mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Ajanta Pharma USA Inc., submitted a citizen petition dated October
11, 2021 (Docket No. FDA-2021-P-1097), and Lachman Consultant Services,
Inc., submitted a citizen petition dated October 13, 2021 (Docket No.
FDA-2021-P-1111), both under 21 CFR 10.30, requesting that the Agency
determine whether PEPCID (famotidine) for oral suspension, 40 mg/5 mL,
was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec. 314.161 that PEPCID (famotidine) for oral
suspension, 40 mg/5 mL, was not withdrawn for reasons of safety or
effectiveness. The petitioners have identified no data or other
information suggesting that PEPCID (famotidine) for oral suspension, 40
mg/5 mL, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
PEPCID (famotidine) for oral suspension, 40 mg/5 mL, 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)
for oral suspension, 40 mg/5 mL, 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. ANDAs that refer to PEPCID (famotidine) for oral
suspension, 40 mg/5 mL, may 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: March 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07391 Filed 4-6-22; 8:45 am]
BILLING CODE 4164-01-P
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