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(FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
US Federal Register - FDA Notices · August 10, 2026
Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined OZOBAX baclofen oral solution was not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.