FDA Clears Path for Flurbiprofen Generic Copies
Published Date: 8/14/2026
Notice
Summary
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(FDA, Agency, or we) has determined that ANSAID (flurbiprofen) tablets, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FDA clears way for generic flurbiprofen
The FDA determined that ANSAID (flurbiprofen) tablets, 50 mg and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination (published August 14, 2026) allows the FDA to approve abbreviated new drug applications (ANDAs) that reference ANSAID 50 mg or 100 mg if those ANDAs meet all other legal and regulatory requirements.
Product stays on Discontinued List; labeling may change
FDA will continue to list ANSAID (flurbiprofen) tablets, 50 mg and 100 mg, in the Orange Book "Discontinued Drug Product List," which denotes products discontinued for reasons other than safety or effectiveness. If FDA determines the drug's labeling should be revised to meet current standards, the Agency will advise ANDA applicants to submit updated labeling.
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