Amneal Pharmaceuticals

Timeline

1. Dec 19, 2025 FDA FDA Original approval: BONCRESA (denosumab-mobz) — BLA761456, Dec 19, 2025. Applicant at approval: Amneal Pharmaceuticals, LLC. Biosimilar. source ↗
2. Dec 19, 2025 FDA FDA Original approval: OZILTUS (denosumab-mobz) — BLA761457, Dec 19, 2025. Applicant at approval: Amneal Pharmaceuticals, LLC. Biosimilar. source ↗
3. May 14, 2025 FDA FDA Original approval: BREKIYA (AUTOINJECTOR) (dihydroergotamine mesylate) — NDA215400, May 14, 2025. Applicant at approval: Amneal Pharmaceuticals. source ↗
4. Jun 3, 2024 Trial start Phase 1: SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal Females source ↗
5. Apr 1, 2024 Trial start Phase 1: A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or O source ↗
6. Jun 29, 2022 Trial start Phase 3: Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes. source ↗
7. 2016-08 Trial start Phase 1: BE Study in Patients - Methotrexate Tablets source ↗
8. 2014-04 Trial start Phase 3: Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee source ↗
9. 2014-03 Trial start Phase 3: Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions source ↗
10. 2014-02 Trial start Phase 2/Phase 3: Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions source ↗
11. 2014-01 Trial start Phase 3: Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis source ↗
12. 2013-11 Trial start Phase 2/Phase 3: Bioequivalence Fasting Study in Patients source ↗
13. 2012-03 Trial start Phase 3: Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo source ↗
14. 2012-02 Trial start Phase 3: Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Ur source ↗
15. 2009-12 Trial start Phase 3: Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo source ↗

Clinical trials (lead sponsor) 12

FDA records (last 2 years)

• Dec 19, 2025 FDA Original approval: BONCRESA (denosumab-mobz) — BLA761456, Dec 19, 2025. Applicant at approval: Amneal Pharmaceuticals, LLC. Biosimilar. source ↗
• Dec 19, 2025 FDA Original approval: OZILTUS (denosumab-mobz) — BLA761457, Dec 19, 2025. Applicant at approval: Amneal Pharmaceuticals, LLC. Biosimilar. source ↗
• May 14, 2025 FDA Original approval: BREKIYA (AUTOINJECTOR) (dihydroergotamine mesylate) — NDA215400, May 14, 2025. Applicant at approval: Amneal Pharmaceuticals. source ↗

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