FDA: Baclofen Oral Solution Safe, Generics Can Proceed
Published Date: 8/10/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Generics Can Still Reference OZOBAX
The FDA determined on August 10, 2026 that OZOBAX (baclofen) oral solution, 5 mg/5 mL (originally approved September 18, 2019 and discontinued by the holder on October 13, 2023) was not withdrawn for reasons of safety or effectiveness. FDA will not begin procedures to withdraw approval of ANDAs that refer to this product, and FDA may continue to approve new ANDAs that refer to it so long as they meet legal and regulatory requirements.
Discontinued but Not Pulled for Safety
The FDA has concluded that OZOBAX (baclofen) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. The product will remain in the Orange Book's "Discontinued Drug Product List" and FDA may continue approving ANDAs that refer to this product if they meet all legal and regulatory requirements.
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