Federal Register #Docket No. FDA-2026-P-1306

FDA Notice on Dexamethasone Elixir, 0.5 mg/5 mL Regulatory Status

This notice from the Food and Drug Administration (FDA) addresses the regulatory status of Dexamethasone Elixir, 0.5 mg/5 mL: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs and Vendors Mentioned: - Wockhardt Bio AG (original ANDA holder) - Pharmobedient Consulting (current ANDA holder) - Lachman Consultant Services, Inc. (citizen petition submitter) - Product Details: - Dexamethasone Elixir, 0.5 mg/5 mL - Indicated for a broad range of medical conditions (endocrine, rheumatic, allergic, etc.) - Notable Requirements: - FDA determined the product was not withdrawn for safety or effectiveness reasons - FDA will continue to approve abbreviated new drug applications (ANDAs) referencing this product if all requirements are met - No procurement, purchase, or award is being announced; no quantities or part numbers are provided

Description

The Food and Drug Administration (FDA) has determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product. FDA will continue to approve ANDAs referring to this product as long as they meet relevant legal and regulatory requirements.

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