Federal Register #FDA-2026-P-6298

FDA Confirms OZOBAX (Baclofen) Oral Solution Not Withdrawn for Safety or Effectiveness

This notice from the Food and Drug Administration (FDA) addresses the regulatory status of OZOBAX (baclofen) oral solution: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Metacel Pharmaceuticals LLC (original manufacturer of OZOBAX) - Novitium Pharma LLC (requestor of the determination) - Products/Services: - OZOBAX (baclofen) oral solution, 5 mg/5 mL - Key Details: - FDA confirms OZOBAX was not withdrawn from sale for safety or effectiveness reasons - The product was discontinued for reasons unrelated to safety or efficacy - This determination allows continued approval of generic drug applications referencing OZOBAX - OZOBAX will remain listed in the Discontinued Drug Product List section of the Orange Book - No procurement or contract opportunity is announced in this notice

Description

The Food and Drug Administration (FDA) has determined that OZOBAX (baclofen) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not withdraw approval of abbreviated new drug applications (ANDAs) referring to this drug and can continue to approve ANDAs that meet legal and regulatory requirements. OZOBAX is indicated for the treatment of spasticity resulting from multiple sclerosis. The drug was discontinued but not for safety or effectiveness reasons, allowing continued marketing and approval of generic versions.

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