Opportunity
Federal Register #2026-20460
FDA correction retains approval of Sawai USA’s dimethyl fumarate ANDA
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 06, 2026
Identifier
2026-20460
The FDA issued a regulatory correction concerning approval of a dimethyl fumarate drug application, not a procurement solicitation. - Government buyer / agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no purchasing office or buyer is identified. - Companies named: Upsher-Smith Laboratories, LLC, acting as U.S. Agent for Sawai USA, Inc.; Teva Pharmaceuticals USA, Inc. is also named in the notice title. - Regulatory matter: The correction removes ANDA 210285 for dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, from a notice of application-approval withdrawals because a request was made to keep the approval in effect. - Procurement status: No products or services are being solicited; no procurement quantities, contract value, or performance period are provided.
Description
The FDA is correcting its May 7, 2026, notice concerning withdrawal of approval of 15 abbreviated new drug applications, effective June 8, 2026. The earlier notice incorrectly included ANDA 210285 for dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, held by Upsher-Smith Laboratories, LLC, U.S. Agent for Sawai USA, Inc. The company timely requested that the ANDA approval not be withdrawn, so its approval remains in effect. This correction removes the ANDA 210285 entry from the earlier notice.