[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20419-20420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of 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(mg)/5 milliliters (mL), was not withdrawn from sale for reasons of 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, 
[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

[[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


