FDA drug application notices distinguish withdrawals from preserved approvals
Oct 11, 2026 edition · GC-2026-0292 · Published 2026-10-11 · Version 3 · Final
October FDA notices have different effects: specific approvals are withdrawn, four mistakenly listed ANDAs remain approved, and two discontinued products remain eligible generic references. A separate oxandrolone correction confirms safety/effectiveness withdrawals, so discontinuation cannot be treated as one uniform regulatory outcome.
What happened
FDA withdrew Amneal celecoxib ANDA 208833 on October 9 after the applicant's request and waived hearing; the notice describes unresolved bioequivalence-data concerns and reports that the products had never been commercially manufactured. A separate 37-ANDA notice withdraws approval November 9, including each application's strengths or forms omitted from its table. Its inventory provision permits dispensing stock on that date only until depletion, expiration, or other violation, whichever comes first. Those application-specific actions do not withdraw every manufacturer's version of the named ingredient.
Other notices correct prior withdrawal lists: Navinta ANDAs 207366, 212957, and 218638 and dimethyl-fumarate ANDA 210285 remain approved after timely requests to preserve them. The Oxandrin correction instead confirms that the identified oxandrolone ANDAs were also withdrawn for safety or effectiveness and are removed from the Orange Book. Separately, pralidoxime autoinjector 600 mg/2 mL and LASIX oral solution 10 mg/mL were determined not withdrawn for safety or effectiveness, preserving qualifying generic-reference pathways subject to other requirements. These distinctions separate approval withdrawal, corrected retained approval, and commercial discontinuation rather than infer a recall or universal therapeutic-equivalence result.
Scope and timing
- Authority status
- Final
- Applicability
- Operationally relevant
- Audience
- Health systems, Provider networks, Health-tech
- Jurisdiction
- Federal
Why it matters
The oxandrolone correction adds five ANDAs to a safety/effectiveness determination and Orange Book removal; the underlying approval withdrawals occurred in 2023 and, for Roxane, 2009. Application-specific status changes must not be generalized to every product or treated as a new broad October ban. A discontinued reference product is not automatically a safety withdrawal.
Recommended action
Pharmacy and procurement should reconcile application numbers and supplier products, document permitted inventory treatment, and correct catalogs that mistakenly removed preserved approvals.
Sources
- 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 MilligramsOfficial · HHS · 2026-10-09 · Source review 2026-10-11
- Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug ApplicationsOfficial · HHS · 2026-10-09 · Source review 2026-10-11
- Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; CorrectionOfficial · HHS · 2026-10-09 · Source review 2026-10-11
- Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; CorrectionOfficial · HHS · 2026-10-06 · Source review 2026-10-11
- Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; CorrectionOfficial · HHS · 2026-10-07 · Source review 2026-10-11
- LASIX oral solution not withdrawn for safety or effectivenessOfficial · FDA · 2026-10-09 · Source review 2026-10-11
- Pralidoxime autoinjector not withdrawn for safety or effectivenessOfficial · FDA · 2026-10-06 · Source review 2026-10-11
- FDA LASIX determination, retained official PDFOfficial · FDA · 2026-10-09 · Source review 2026-10-11
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