Latest Generic Drug Approvals

First-Time Generics are the very first generic versions of marketed brand-name drug products to be approved by the FDA. The generic version is formulated to work in the same way as the brand-name product and provides the same clinical benefit.

See also: New drug approvals, New drug applications, Generic drugs

First-time generic approvals 2025

March

• Rivaroxaban Tablets 2.5 mg
  Approved: March 3, 2025 - Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd.
  Treatment for: Treatment and Prevention of Blood Clots
  Generic for: Xarelto 2.5 mg
• Pralatrexate Injection 20 mg/1 mL and 40 mg/2 mL
  Approved: March 10, 2025 - Dr. Reddy's Laboratories Limited
  Treatment for: Peripheral T-Cell Lymphoma
  Generic for: Folotyn
• Eluxadoline Tablets 75 mg and 100 mg
  Approved: March 14, 2025 - Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Irritable Bowel Syndrome with Diarrhea (IBS-D)
  Generic for: Viberzi
• Apalutamide Tablets 60 mg
  Approved: March 17, 2025 - Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Prostate Cancer
  Generic for: Erleada 60 mg
• Bimatoprost Ophthalmic Solution 0.01%
  Approved: March 17, 2025 - Mankind Pharma Limited
  Treatment for: Glaucoma
  Generic for: Lumigan
• Lidocaine Topical Patch 1.8%
  Approved: March 25, 2025 - Aveva Drug Delivery Systems Inc.
  Treatment for: Post-Herpetic Neuralgia
  Generic for: ZTlido

February

• Bosentan Tablets for Oral Suspension 32 mg
  Approved: February 5, 2025 - Natco Pharma USA LLC
  Treatment for: Pulmonary Arterial Hypertension
  Generic for: Tracleer Tablets for Oral Suspension
• Gadoteridol Injection 279.3 mg/mL
  Approved: February 11, 2025 - Hainan Poly Pharm Co., Ltd.
  Treatment for: Magnetic Resonance Imaging
  Generic for: ProHance
• Mercaptopurine Oral Suspension 20 mg/mL
  Approved: February 26, 2025 - Hikma Pharmaceuticals USA Inc.
  Treatment for: Acute Lymphoblastic Leukemia
  Generic for: Purixan

January

• Mesna Tablets 400 mg
  Approved: January 13, 2025 - Riconpharma LLC
  Treatment for: Hemorrhagic Cystitis Prophylaxis
  Generic for: Mesnex Tablets
• Eltrombopag Olamine Tablets 12.5 mg (free acid), 25 mg (free acid), 50 mg (free acid) and 75 mg (free acid)
  Approved: January 17, 2025 - Hetero Labs Limited, Unit V
  Treatment for: Thrombocytopenia, Aplastic Anemia
  Generic for: Promacta Tablets
• Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg/12.5 mg and 40 mg/25 mg
  Approved: January 21, 2025 - Alkem Laboratories Limited
  Treatment for: Hypertension
  Generic for: Edarbyclor

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