The Food and Drug Administration (FDA, Agency, or we) has determined that ANSAID (flurbiprofen) tablets, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurbiprofen tablets, 50 mg and 100 mg, if all other legal and regulatory requirements are met.
US Federal Register - FDA Notices · August 14, 2026
Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined flurbiprofen tablets 50 mg and 100 mg were not withdrawn for safety or effectiveness reasons, permitting ANDA approvals.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.