In 2025, the FDA approved 73 first-time generic drugs.
Here are the generics and their indication, in order of approval date:
Note: The FDA’s information is current as of Dec. 18.
1. Phytonadione injection — For select coagulation disorders.
2. Esomeprazole magnesium for suspension — For short-term treatment of erosive esophagitis.
3. Regorafenib tablet — For metastatic colorectal cancer.
4. Mesna tablet — For reducing incidence of ifosfamide-induced hemorrhagic cystitis.
5. Ephedrine sulfate injection — For clinically important hypotension occurring in the setting of anesthesia.
6. Eltrombopag olamine tablet — For select cases of thrombocytopenia.
7. Azilsartan medoxomil and chlorthalidone tablet — For hypertension.
8. Nimodipine solution — For reducing the incidence and severity of ischemic deficits in select cases of subarachnoid hemorrhage.
9. Ivermectin tablet — For treatment of intestinal strongyloidiasis.
10. Bosentan tablet for suspension — For pulmonary arterial hypertension.
11. Epinephrine injection — For increasing mean arterial blood pressure in adults with hypotension associated with septic shock.
12. Selenious acid injection — For patients as a source of selenium for parenteral nutrition.
13. Gadoteridol injection — For magnetic resonance imaging.
14. Phenylephrine hydrochloride injection — For clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
15. Mercaptopurine suspension — For acute lymphoblastic leukemia.
16. Rivaroxaban tablet — For reducing the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
17. Pralatrexate injection — For relapsed or refractory peripheral T-cell lymphoma.
18. Fludeoxyglucose F-18 injection — For abnormal glucose metabolism to assist in evaluation of malignancy.
19. Buspirone hydrochloride capsule — For anxiety disorders.
20. Eluxadoline tablet — For irritable bowel syndrome with diarrhea.
21. Bimatoprost drop — For reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
22. Apalutamide tablet — For metastatic castration-sensative prostate cancer and non-metastatic castration-resistant prostate cancer.
23. Lidocaine patch — For relief of pain association with post-herpetic neuralgia.
24. Technetium TC-99M pentetate acid kit injection — For brain imaging.
25. Acetaminophen injection — For mild to moderate pain management.
26. Nitroglycerin ointment — For preventing angina pectoris due to coronary artery disease.
27. Siponimod tablet — For relapsing forms of multiple sclerosis in adults.
28. Tolvaptan tablet — For slowing kidney function decline in select adults.
29. Naloxone hydrochloride nasal spray — For emergency treatment of opioid overdose.
30. Pilocarpine hydrochloride solution/drop — For presbyopia.
31. Latanoprostene bunod solution/drop — For reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
32. Midazolam in 0.8% sodium chloride injection — For sedation.
33. Halobetasol propionate and tazarotene lotion — For plaque psoriasis.
34. Raltegravir potassium tablet — For treatment of human immunodeficiency virus (HIV-1) infection.
35. Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablet — For treatment of HIV-1 infection.
36. Perampanel tablet — For partial-onset seizures.
37. Bosutinib monohydrate tablet — For chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.
38. Magnesium sulfate injection — For replacement therapy in magnesium deficiency.
39. Methylnaltrexone bromide injection — For opioid-induced constipation in adults with chronic non-cancer pain.
40. Angiotensin II acetate injection — For increasing blood pressure in adults with septic or other distributive shock.
41. Sitagliptin and metformin extended-release tablet — For improving glycemic control in adults with Type 2 diabetes.
42. Selenious acid injection — For adult and pediatric patients as a source of selenium for parenteral nutrition.
43. Dehydrated alcohol injection — For inducing controlled cardiac septal infarction to improve exercise capacity in select adults with symptomatic hypertrophic obstructive cardiomyopathy.
44. Meropenem powder for injection — For bacterial meningitis.
45. Rivaroxaban granule for suspension — For reducing the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
46. Loteprednol etabonate gel — For treating postoperative inflammation and pain following ocular surgery.
47. Manganese chloride injection — For adult patients as a supplement to intravenous solutions given for TPN.
48. Perampanel suspension — For treatment of partial-onset seizures.
49. Sertraline hydrochloride capsule — For major depressive disorder.
50. Darunavir tablet — For HIV-1 infection.
51. Tazarotene lotion — For acne vulgaris.
52. Ascorbic acid injection — For short-term treatment of scurvy.
53. Baricitinib tablet — For moderately to severely active rheumatoid arthritis.
54. Iron sucrose injection — For treatment of iron deficiency anemia in patients with chronic kidney disease.
55. Cangrelor powder for injection — For reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in select patients.
56. Norepinephrine bitartrate in 5% dextrose injection — For raising blood pressure in adults with severe, acute hypotension.
57. Liraglutide injection — For weight reduction in patients with obesity or those with at least one weight-related comorbid condition and overweight.
58. Pazopanib hydrochloride tablet — For advanced renal cell carcinoma.
59. Ketamine hydrochloride injection — For diagnostic and surgical procedures that do not require skeletal muscle relaxation.
60. Progesterone vaginal insert — For supporting embryo implantation and early pregnancy.
61. Gallium Ga 68 edotreotide injection — For use with positron emission tomography.
62. Dalbavancin hydrochloride powder for injection — For treatment of acute bacterial skin and skin structure infections caused by select microorganisms.
63. Lomustine capsule — For treatment of primary and metastatic brain tumors.
64. Drospirenone and estradiol tablet — For moderate to severe vasomotor symptoms.
65. Axitinib tablet — For treatment of advanced renal cell carcinoma.
66. Ciprofloxacin hydrochloride and hydrocortisone suspension/drop — For acute otitis externa.
67. Diroximel fumarate delayed-release capsule — For relapsing forms of multiple sclerosis.
68. Iohexol injection — For myelography and computerized tomography myelography.
69. Diazepam rectal gel delivery system — For acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
70. Voriconazole injection — For treatment of invasive aspergillosis.
71. Cladribine tablet — For relapsing forms of multiple sclerosis.
72. Sitagliptin and metformin hydrochloride tablet — For improving glycemic control in adults with Type 2 diabetes.
73. Estradiol vaginal insert — For moderate to severe dyspareunia due to menopause.
