Opportunity
Federal Register #2026-21897
FDA determination concerning PEPCID RPD famotidine tablets and potential generic approvals
Buyer
Food and Drug Administration
Posted
October 27, 2026
Identifier
2026-21897
The FDA issued a regulatory determination concerning PEPCID RPD famotidine tablets, rather than a request to purchase products or services. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Product: PEPCID RPD (famotidine) orally disintegrating tablets, associated with NDA 020752 and Merck & Co., Inc. and Merck Sharp & Dohme Corp. - 20 mg strength; no procurement quantity or part number specified. - 40 mg strength; no procurement quantity or part number specified. - The FDA determined the products were not withdrawn from sale for safety or effectiveness reasons and will continue listing them in the Orange Book’s Discontinued Drug Product List. - FDA may approve abbreviated new drug applications (ANDAs) referencing these products if applicants meet all other applicable requirements. - Lachman Consultant Services, Inc. is identified as the citizen-petition submitter; it is not identified as a supplier. - No goods or services are being procured, and no contract value or performance period is provided.
Description
The FDA determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. The products will remain listed in the Discontinued Drug Product List section of the Orange Book. FDA may approve abbreviated new drug applications (ANDAs) referring to these products if all other legal and regulatory requirements are met.