FDA CDER Logs 13 First Generic Approvals in Final Months of 2025 Across Key Therapeutic Categories

Brand manufacturers holding reference listed drug status in diabetes, multiple sclerosis, and respiratory therapy face a materially altered competitive landscape after FDA's Center for Drug Evaluation and Research (CDER) logged at least 13 first-time generic approvals between October and December 2025. For QA directors and regulatory affairs leads at originator sites, each ANDA clearance signals that a competing manufacturer has satisfied 21 CFR Part 314 bioequivalence and chemistry, manufacturing, and controls requirements sufficient to enter the market.

The diabetes category absorbed two approvals in the final month of the year. Watson Laboratories secured the first generic for Januvia (sitagliptin phosphate tablets) on 30 December 2025, while Sandoz cleared the first generic for Janumet (sitagliptin and metformin hydrochloride tablets) on 2 December 2025, compressing the exclusivity window on both Merck reference products within a single quarter.

The neurology segment drew significant ANDA activity. Apotex received first-generic status for Mavenclad (cladribine tablets) on 24 November 2025 and for Inlyta (axitinib tablets) on 30 October 2025. Zydus Worldwide DMCC cleared the first generic for Vumerity (diroximel fumarate delayed-release capsules) on 12 November 2025, covering relapsing forms of MS including clinically isolated syndrome and active secondary progressive disease. Navinta LLC gained approval for a generic diazepam rectal gel delivery system referencing Diastat on 14 November 2025, relevant to acute seizure cluster management in patients aged two and older.

Respiratory and inhalation manufacturing teams should note Amneal Ireland Limited's 16 December approval for a generic beclomethasone dipropionate metered-dose inhaler referencing Qvar, an approval category where sterility assurance, propellant specifications, and device comparability data carry elevated CMC scrutiny. Aurobindo Pharma Limited cleared a pseudoephedrine hydrochloride extended-release tablet referencing Sudafed 24 Hour on 29 December 2025.

Additional approvals span ophthalmology, oncology, and injectable contrast media. Alembic Pharmaceuticals received clearance for a loteprednol etabonate and tobramycin ophthalmic suspension referencing Zylet on 10 December 2025. Teva Pharmaceuticals USA gained approval for an estradiol vaginal insert referencing Imvexxy on 8 December 2025. Hainan Poly Pharm. Co., Ltd. cleared a voriconazole injection referencing Vfend on 14 November 2025, and Amneal EU, Limited secured approval for an iohexol injection referencing Omnipaque on 13 November 2025. Cosette Pharmaceuticals NC Laboratories cleared a ciprofloxacin hydrochloride and hydrocortisone otic suspension referencing Cipro HC on 10 November 2025.

CDER notes that approval date does not guarantee commercial availability; ANDA holders determine launch timing independently, meaning brand site operations teams should monitor applicant-level supply disclosures before adjusting demand forecasts or site capacity planning.

Source: FDA CDER via What's New: Drugs RSS Feed, 22 May 2026.