Federal Register #2026-16666

FDA Notice: ANSAID (Flurbiprofen) Tablets Not Withdrawn for Safety or Effectiveness

This notice from the Food and Drug Administration (FDA) provides an update on the regulatory status of ANSAID (flurbiprofen) tablets: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEM Highlight: - Pharmacia and Upjohn Company is the original manufacturer of ANSAID (flurbiprofen) tablets (NDA 018766) - Products/Services Mentioned: - ANSAID (flurbiprofen) tablets, 50 mg and 100 mg strengths - Key Details: - The FDA confirms these products were not withdrawn from sale for reasons of safety or effectiveness - The products remain listed in the Discontinued Drug Product List in the FDA's Orange Book, indicating discontinuation for reasons other than safety or effectiveness - This determination allows for the submission and potential approval of abbreviated new drug applications (ANDAs) for generic versions of flurbiprofen tablets, provided all other requirements are met - No procurement action is requested; no product quantities, part numbers, or purchasing requirements are included in this notice

Description

The Food and Drug Administration (FDA) has determined that ANSAID (flurbiprofen) tablets, 50 mg and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for these flurbiprofen tablets if all other legal and regulatory requirements are met. The notice clarifies that the drug products remain listed in the Discontinued Drug Product List section of the Orange Book, indicating discontinuation for reasons other than safety or effectiveness. The FDA reviewed the citizen petition and agency records and found no evidence suggesting withdrawal for safety or effectiveness reasons.

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