FDA Determines OZOBAX (Baclofen) Oral Solution Was Not Withdrawn for Safety or Effectiveness Reasons

The U.S. Food and Drug Administration (FDA) has determined that OZOBAX (baclofen) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness.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 decision allows the FDA to continue approving abbreviated new drug applications (ANDAs) that refer to this product, facilitating the availability of generic versions for the treatment of spasticity.