Federal Register #2026-05913

FDA Correction Notice: ANDA 070631 Approval for Valproic Acid Remains in Effect

This notice provides a correction from the Food and Drug Administration (FDA) regarding the withdrawal of drug application approvals: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Upsher-Smith Laboratories, LLC (holder of ANDA 070631) - Products/Services: - No procurement of products or services is announced - Correction pertains to ANDA 070631 for valproic acid, capsule, 250 mg - Unique/Notable Requirements: - The correction clarifies that approval for ANDA 070631 remains in effect due to a timely request from Upsher-Smith Laboratories, LLC - No solicitation, procurement, or contract award is involved - Locations: - FDA headquarters in Silver Spring, MD - National Eye Institute in Bethesda, MD (mentioned in context) - No estimated contract value, product line items, or service line items are present, as this is not a procurement opportunity.

Description

The Food and Drug Administration (FDA) issued a correction to a previous notice regarding the withdrawal of approval of 72 abbreviated new drug applications (ANDAs). Specifically, the correction clarifies that the approval for ANDA 070631 for valproic acid, capsule, 250 milligrams, held by Upsher-Smith Laboratories, LLC, remains in effect because the company timely requested that the approval not be withdrawn. This correction rectifies the earlier error that had indicated the approval was withdrawn effective October 23, 2025.

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