Federal Register #FDA-2026-P-7537

FDA determination regarding CARAFATE (Sucralfate) oral suspension, 1 gram/10 milliliters

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, addresses the regulatory status of CARAFATE (sucralfate) oral suspension, 1 gram/10 milliliters. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Abbvie, Inc. (original NDA holder) - Aurobindo Pharma USA, Inc. (citizen petition submitter) - Product Details: - CARAFATE (sucralfate) oral suspension, 1 gram/10 milliliters - NDA 019183 - Indicated for short-term treatment of active duodenal ulcer - Unique/Notable Requirements: - FDA determined the drug was not withdrawn for safety or effectiveness reasons - FDA will continue to approve abbreviated new drug applications (ANDAs) referencing this drug, if all legal and regulatory requirements are met - Drug is listed in the Discontinued Drug Product List section of the Orange Book - Review included a citizen petition and FDA's own records and literature - No procurement or award is announced in this notice

Description

The Food and Drug Administration (FDA) has determined that CARAFATE (sucralfate) oral suspension, 1 gram/10 milliliters, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to continue approving abbreviated new drug applications (ANDAs) referring to this drug product as long as they meet legal and regulatory requirements. CARAFATE is indicated for the short-term treatment of active duodenal ulcer and is currently listed in the Discontinued Drug Product List section of the Orange Book. The FDA reviewed the citizen petition and agency records and found no information indicating withdrawal for safety or effectiveness reasons.

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