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Federal RegisterGovernmentRegulationFDA Drug ApprovalPharmaceutical RegulationCelecoxib Withdrawal

Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

By Health, Drug Administration, Human Services Department, Food · Oct 8, 2026, 11:00 PM CDT

Read full article at Federal Register
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

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Drug Administration →Human Services Department, Food →

Layer 1 · Claims & fact checks

AI analysis

Layer 2 · Biblical perspective

Biblical interpretation
INSUFFICIENT CONTEXT
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Layer 3 · Reporting analysis

AI analysis

neutral factual statementThe sentence presents the core action without evaluative language, indicating a straightforward report.

neutral factual statementThis sentence reports Amneal's procedural choice without commentary, maintaining a neutral tone.

Context

AI analysis

Missing context

The notice does not explain why Amneal requested the withdrawal, what regulatory or commercial factors prompted the decision, or what impact the withdrawal will have on patients, prescribers, or the market for celecoxib.

Important context

FDA withdrawals of ANDA approvals are typically based on issues such as manufacturing problems, data deficiencies, or strategic business decisions. The waiver of a hearing indicates Amneal chose not to contest the withdrawal.

Opinion vs. reporting

AI analysis

The content consists solely of factual reporting of an FDA action and Amneal's request; no opinion or editorializing is present.