Phantom Celecoxib Capsules: Approved, Unsold, Now FDA-Yanked After 8 Years
Published Date: 10/9/2026
Notice
Summary
Amneal Pharmaceuticals asked the FDA to withdraw approval for their Celecoxib capsules in all strengths, effective October 9, 2026. This affects patients and pharmacies relying on Amneal’s version of this pain relief medicine, as it will no longer be available. The change comes after concerns about the drug’s testing data, and Amneal never actually sold the capsules since approval in 2018.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Amneal's Celecoxib Approval Withdrawn
Amneal asked the FDA to withdraw approval for its Celecoxib capsules (50 mg, 100 mg, 200 mg, and 400 mg), and approval is withdrawn effective October 9, 2026. If you or your pharmacy relied on Amneal's version of this pain medicine, that approved product is no longer approved after that date.
Product Not Manufactured; Moved to Discontinued List
FDA records show Amneal's Celecoxib capsules approved in May 2018 were not commercially manufactured after approval, and in November 2024 they were moved to the discontinued section of the Orange Book. That listing indicates Amneal's versions were not being sold before the October 9, 2026 withdrawal.
Distributing Withdrawn Product Is Illegal
After October 9, 2026, distributing Amneal's Celecoxib capsules (50 mg, 100 mg, 200 mg, 400 mg) into interstate commerce without an approved application is illegal and subject to regulatory action under the Federal Food, Drug, and Cosmetic Act.
FDA Raised Bioequivalence Data Concerns
FDA notified Amneal on September 16, 2021, that there were significant concerns about the validity and reliability of bioequivalence and bioavailability data for ANDA 208833 and instructed Amneal to re-conduct bioequivalence studies at an alternate site; FDA also changed the Orange Book therapeutic equivalence code to 'BX'.
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