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 2024
April
- Valbenazine Tosylate Capsules 40 mg (base) and 80 mg (base)
Approved: April 5, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Huntington’s Disease, Tardive Dyskinesia
Generic for: Ingrezza - Eribulin Mesylate Intravenous Solution 1 mg/2 mL (0.5 mg/mL)
Approved: Approved: April 5, 2024 - Gland Pharma Limited
Treatment for: Breast Cancer, Liposarcoma
Generic for: Halaven - Doxycycline (Anhydrous) Immediate/Delayed Release Capsules 40 mg
Approved: April 8, 2024 - Dr. Reddys Laboratories Inc.; Lupin Pharmaceuticals, Inc.
Treatment for: Rosacea
Generic for: Oracea - Estradiol Transdermal Gel (Metered) 0.06% (1.25 g/activation)
Approved: April 22, 2024 - Solaris Pharma Corporation
Treatment for: Menopausal Symptoms
Generic for: EstroGel - Deflazacort Oral Suspension 22.75 mg/mL
Approved: April 25, 2024 - Tris Pharma Inc.
Treatment for: Duchenne Muscular Dystrophy
Generic for: Emflaza Suspension - Midostaurin Capsules 25 mg
Approved: April 29, 2024 - Teva Pharmaceuticals USA, Inc.
Treatment for: Acute Myeloid Leukemia, Systemic Mastocytosis
Generic for: Rydapt
March
- Finasteride and Tadalafil Capsules 5 mg / 5 mg
Approved: March 15, 2024 - Zydus Worldwide DMCC
Treatment for: Benign Prostatic Hyperplasia
Generic for: Entadfi
February
- Bromfenac Sodium Sesquihydrate Ophthalmic Solution 0.075% (free acid)
Approved: February 2, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation
Generic for: BromSite - Cobicistat Tablets 150 mg
Approved: February 7, 2024 - Mylan Pharmaceuticals Inc.
Treatment for: HIV Infection
Generic for: Tybost - Deflazacort Tablets 6 mg, 18 mg, 30 mg and 36 mg
Approved: February 9, 2024 - Aurobindo Pharma Limited
Treatment for: Duchenne Muscular Dystrophy
Generic for: Emflaza - Ospemifene Tablets 60 mg
Approved: February 13, 2024 - Hetero Labs Limited
Treatment for: Menopause Symptoms
Generic for: Osphena - Brimonidine Tartrate Ophthalmic Solution 0.025%
Approved: February 16, 2024 - Dr.Reddy's Laboratories Inc.
Treatment for: Eye Redness
Generic for: Lumify - Nitroglycerin Intra-Anal Ointment 0.4%
Approved: February 16, 2024 - Cosette Pharmaceuticals, Inc.
Treatment for: Anal Fissure
Generic for: Rectiv
January
- Nilotinib Hydrochloride Capsules 50mg (base), 150mg (base) and 200mg (base)
Approved: January 5, 2024 - Apotex Corp.
Treatment for: Chronic Myeloid Leukemia
Generic for: Tasigna - Fidaxomicin Tablets 200 mg
Approved: January 16, 2024 - Actavis Laboratories FL, Inc.
Treatment for: Clostridioides difficile-Associated Diarrhea
Generic for: Dificid - Pimavanserin Tartrate Capsules 34 mg (base)
Approved: January 16, 2024 - MSN Laboratories Private Limited; Zydus Pharmaceuticals USA Inc.
Treatment for: Parkinson's Disease Psychosis
Generic for: Nuplazid Capsules - Pimavanserin Tartrate Tablets 10 mg (base)
Approved: January 16, 2024 - Zydus Pharmaceuticals USA Inc.
Treatment for: Parkinson's Disease Psychosis
Generic for: Nuplazid Tablets - Dronedarone Hydrochloride Tablets 400 mg (base)
Approved: January 31, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Atrial Fibrillation
Generic for: Multaq
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