First Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.
“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.
Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.
First-Time Generic Drug Approvals 2024*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 58 | 216936 | Drospirenone Tablets, 4 mg | Lupin Limited | Slynd (Drospirenone Tablets) | 9/30/2024 | For use by females of reproductive potential to prevent pregnancy |
| 57 | 218112 | Dexmedetomidine Injection USP, 400 mcg/4 mL (100 mcg/mL) and 1000 mcg/10 mL (100 mcg/mL) Multiple-Dose Vials |
Somerset Therapeutics, LLC | Dexmedetomidine Injection | 9/24/2024 | For the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; for them edation of non-intubated patients prior to and/or during surgical and other procedures |
| 56 | 215592 | Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL), Single-Dose Containers | Cipla Limited | Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection | 9/24/2024 | For the short-term treatment of hypertension when oral therapy is not feasible |
| 55 | 208112 | Methylnaltrexone Bromide Injection, 8 mg/0.4 mL and 12 mg/0.6 mL, Single-Dose Prefilled Syringes | Actavis LLC | Relistor (Methylnaltrexone Bromide) Injection | 8/26/2024 | For the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain; for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care |
| 54 | 214897 | Amantadine Extended-Release Capsules, 68.5 mg | Zydus Worldwide DMCC | Gocovri (Amantadine) Extended-Release Capsules | 8/26/2024 | For the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| 53 | 216035 | Riluzole Oral Suspension, 50 mg/10 mL (5 mg/mL) | Alkem Laboratories Limited | Tiglutik (Riluzole) Oral Suspension | 8/22/2024 | For the treatment of amyotrophic lateral sclerosis (ALS) |
| 52 | 218613 | Lofexidine Tablets, 0.18 mg | Indoco Remedies Limited | Lucemyra (Lofexidine) Tablets | 8/20/2024 | For the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults |
| 51 | 216137 | Valbenazine Capsules, 40 mg, 60 mg, and 80 mg | Zydus Worldwide DMCC | Ingrezza (Valbenazine) Capsules | 8/7/2024 | For the treatment of adults with tardive dyskinesia |
| 50 | 219002 | Trametinib Tablets, 0.5 mg and 2 mg | Novugen Oncology Sdn. Bhd. | Mekinist (Trametinib) Tablets | 8/6/2024 | For the treatment of patients with melanoma with BRAF V600E or V600K mutations; patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation; patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation; adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation; pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation |
| 49 | 216935 | Prednisolone Acetate Ophthalmic Suspension USP, 1% | Lupin Limited | Pred Forte (Prednisolone Acetate) Ophthalmic Suspension | 8/2/2024 | Reduces the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye |
| 48 | 216021 | Pantoprazole Sodium for Injection, 40 mg per Vial (Single-Dose Vial) | Fresenius Kabi USA, LLC | Pantoprazole Sodium for Injection | 8/1/2024 | For the short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE); for the treatment of pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome |
| 47 | 217542 | Baricitinib Tablets, 1 mg, 2 mg | Aurobindo Pharma USA, Inc. | Olumiant (Baricitinib) Tablets | 7/22/2024 | "the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers" |
| 46 | 217075 | Tazarotene Cream, 0.05% | Padagis Israel Pharmaceuticals Ltd | Tazorac (Tazarotene) Cream | 7/15/2024 | Indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs |
| 45 | 216937 | Nimodipine Oral Solution, 60 mg/20 mL (3 mg/ mL) | Annora Pharma Private Limited | Nymalize (Nimodipine) Oral Solution | 7/9/2024 | For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage |
| 44 | 215647 | L-Glutamine Oral Powder, 5 grams/packet | Novitium Pharma LLC | Endari (L-Glutamine) Oral Powder | 7/8/2024 | To reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older |
| 43 | 212785 | Indium In-111 Pentetreotide Kit for Injection, 3 mCi/mL | Sun Pharmaceutical Industries, Inc. | Octreoscan (Kit for the Preparation of Indium In 111 Pentetreotide) | 7/2/2024 | For the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors |
| 42 | 214348 | Bupivacaine Liposome Injectable Suspension, 1.3% (133 mg/10 mL) and 1.3% (266 mg/20 mL) Single-Dose Vials | Jiangsu Hengrui Pharmaceuticals Co., Ltd | Exparel (Bupivacaine Liposome) Injectable Suspension | 7/1/2024 | Indicated to produce postsurgical local analgesia via infiltration in adults; regional analgesia via an interscalene brachial plexus nerve block in adults |
| 41 | 204982 | Phentermine and Topiramate Extended-release Capsules, 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25mg /69 mg, 15 mg/92 mg | Actavis Laboratories FL, Inc. | Qsymia (Phentermine and Topiramate) Extended-release Capsule | 6/25/2024 | Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients |
| 40 | 213688 | 0.9% Sodium Chloride Irrigation USP, 1,000 mL, 2,000 mL, 3,000 mL Single-Dose Containers | Fresenius Kabi USA, LLC | Sodium Chloride Injection 0.9% | 6/24/2024 | For all general irrigation, washing, rinsing, dilution purposes which permit use of a sterile, non-pyrogenic electrolyte solution |
| 39 | 209266 | Avanafil Tablets, 50 mg, 100 mg, 200 mg | Hetero Labs Limited Unit V | Stendra (Avanafil) Tablets | 6/14/2024 | For the treatment of erectile dysfunction |
| 38 | 215570 | Palbociclib Tablets, 75 mg, 100 mg, 125 mg | Synthon Pharmaceuticals, Inc | Ibrance (Palbociclib) Tablets | 6/2/2024 | For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy or fulvestrant in patients with disease progression following endocrine therapy |
| 37 | 217671 | Halcinonide Topical Solution USP, 0.1% | Encube Ethicals Private Limited | Halog (Halcinonide) Topical Solution | 5/29/2024 | For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses |
| 36 | 216421 | Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray) | Apotex Inc. | Astepro (Azelastine Hydrochloride) Nasal Spray OTC | 5/29/2024 | Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies |
| 35 | 213682 | Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg | Alembic Pharmaceuticals Limited | Entresto (Sacubitril and Valsartan ) Tablets | 5/28/2024 | To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older |
| 34 | 213676 | Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg | Laurus Labs Limited | Entresto (Sacubitril and Valsartan ) Tablets | 5/28/2024 | To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older |
| 33 | 213605 | Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg | Crystal Pharmaceutical (Suzhou) Co., Ltd. | Entresto (Sacubitril and Valsartan) Tablets | 5/28/2024 | To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older |
| 32 | 216343 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% | Amneal EU, Limited | Timolol Maleate Ophthalmic Gel Forming Solution | 5/23/2024 | For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma |
| 31 | 217193 | Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL, Single-Dose | InvaGen Pharmaceuticals, Inc. | Somatuline Depot (Lanreotide) Injection | 5/21/2024 | For the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; for the treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival; for the treatment of adults with carcinoid syndrome |
| 30 | 214053 | Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg and 120 mg/15 mg | Apotex Inc. | Descovy (Emtricitabine and Tenofovir Alafenamide) Tablets | 5/17/2024 | In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg; in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg; indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) |
| 29 | 218354 | Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single Dose Bags | Long Grove Pharmaceuticals, LLC | Radicava (Edaravone) Injection | 5/6/2024 | For the treatment of amyotrophic lateral sclerosis |
| 28 | 216199 | Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags | Gland Pharma Limited | Radicava (Edaravone) Injection | 5/6/2024 | For the treatment of amyotrophic lateral sclerosis |
| 27 | 215917 | Edaravone Injection, 60 mg/100 mL (0.6 mg/mL), Single-Dose Bag | Dr. Reddy's Laboratories Limited | Radicava (Edaravone) Injection | 5/6/2024 | For the treatment of amyotrophic lateral sclerosis |
| 26 | 215508 | Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single-Dose Vials | Hikma Pharmaceuticals USA, Inc. | Radicava (Edaravone) Injection | 5/6/2024 | For the treatment of amyotrophic lateral sclerosis |
| 25 | 217791 | Atropine Sulfate Ophthalmic Solution USP, 1% | Somerset Therapeutics, LLC | Isopto Atropine (Atropine Sulfate) Ophthalmic Solution | 4/29/2024 | Indicated for mydriasis; cycloplegia; penalization of the healthy eye in the treatment of amblyopia |
| 24 | 216076 | Midostaurin Capsules, 25 mg | Teva Pharmaceuticals Development, Inc | Rydapt (Midostaurin) Capsules | 4/29/2024 | For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive; for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia |
| 23 | 217813 | Deflazacort Oral Suspension, 22.75 mg/mL | Tris Pharma, Inc. | Emflaza (Deflazacort) Oral Suspension | 4/25/2024 | For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older |
| 22 | 216160 | Estradiol Gel, 0.06% | Solaris Pharma Corporation | EstroGel (Estradiol) Gel | 4/22/2024 | For the treatment of moderate to severe vasomotor symptoms due to menopause; for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause |
| 21 | 216620 | Eltrombopag for Oral Suspension, 12.5 mg and 25 mg | Annora Pharma Private Limited | Promacta (Eltrombopag) for Oral Suspension | 4/18/2024 | For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy; for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy |
| 20 | 203978 | Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection, 40 mg/200 mL (0.2 mg/mL), Single-Dose Containers and Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL), Single-Dose Containers | InfoRLife SA | Cardene (Nicardipine Hydrochloride) I.V. Premixed injection | 4/17/2024 | For the short-term treatment of hypertension when oral therapy is not feasible |
| 19 | 218034 | Doxycycline Capsules, 40 mg | Dr. Reddy's Laboratories Limited | Oracea (Doxycycline) Capsules | 4/8/2024 | For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients |
| 18 | 216631 | Doxycycline Capsules, 40 mg | Lupin, Inc. | Oracea (Doxycycline) Capsules | 4/8/2024 | For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients |
| 17 | 218047 | Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-dose Vial | Gland Pharma Limited | Halaven (Eribulin Mesylate) Injection | 4/5/2024 | For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease; unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen |
| 16 | 216064 | Valbenazine Capsules, 40 mg, 60 mg, 80 mg | Lupin Limited | Ingrezza (Valbenazine) Capsules | 4/5/2024 | For the treatment of adults with tardive dyskinesia |
| 15 | 216795 | Metronidazole Vaginal Gel, 1.3% | Encube Ethicals | Nuvessa (Metronidazole) Vaginal Gel | 3/18/2024 | For the treatment of bacterial vaginosis in females 12 years of age and older |
| 14 | 218232 | Finasteride and Tadalafil Capsules, 5 mg/5 mg | Zydus Worldwide DMCC | Entadfi (Finasteride and Tadalafil) Capsules | 3/15/2024 | To initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks |
| 13 | 216361 | Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) | Dr. Reddy's Laboratories SA | Lumify (Brimonidine Tartrate) Ophthalmic Solution | 2/16/2024 | Relieves redness of the eye due to minor eye irritations |
| 12 | 216103 | Nitroglycerin Ointment USP, 0.4% | Dr. Reddy's Laboratories SA | Rectiv (Nitroglycerin) Ointment | 2/16/2024 | For the treatment of moderate to severe pain associated with chronic anal fissure |
| 11 | 215574 | Ospemifene Tablets, 60 mg | Hetero Labs Limited Unit V | Osphena (Ospemifene) Tablets | 2/13/2024 | For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause; for the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause |
| 10 | 217123 | Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg | Aurobindo Pharma Limited | Emflaza (Deflazacort) Tablets | 2/9/2024 | For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older |
| 9 | 216899 | Hydromorphone Hydrochloride Injection USP, 0.2 mg/mL, 0.5 mg/0.5 mL,1 mg/mL, 2 mg/mL Single-Dose Prefilled Syringes | Hikma Pharmaceuticals USA, Inc. | Dilaudid (Hydromorphone) Hydrochloride Injection | 2/9/2024 | For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate |
| 8 | 209986 | Cobicistat Tablets, 150 mg | Mylan Laboratories Limited | Tybost (Cobicistat) Tablets | 2/4/2024 | For the treatment of HIV-1 infection in adults and in pediatric patients |
| 7 | 211239 | Bromfenac Ophthalmic Solution, 0.075% | Lupin Limited | BromSite (Bromfenac) Ophthalmic Solution | 2/2/2024 | For the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery |
| 6 | 205904 | Dronedarone Tablets USP, 400 mg | Lupin Inc. | Multaq (Dronedarone) Tablets | 1/31/2024 | To reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF |
| 5 | 214925 | Pimavanserin Capsules, 34 mg | MSN Laboratories Private Limited | Nuplazid (Pimavanserin) Capsules | 1/16/2024 | For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis |
| 4 | 214502 | Pimavanserin Tablets, 10 mg | Zydus Pharmaceuticals (USA) Inc. | Nuplazid (Pimavanserin) Capsules | 1/16/2024 | For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis |
| 3 | 214493 | Pimavanserin Capsules, 34 mg | Zydus Pharmaceuticals (USA) Inc. | Nuplazid (Pimavanserin) Capsules | 1/16/2024 | For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis |
| 2 | 208443 | Fidaxomicin Tablets, 200 mg | Actavis Laboratories FL, Inc. | Dificid (Fidaxomicin) Tablets | 1/16/2024 | For the treatment of C. difficile-associated diarrhea |
| 1 | 203640 | Nilotinib Capsules, 50 mg, 150 mg, 200 mg | Apotex, Inc. | Tasigna (Nilotinib) Capsules | 1/5/2024 | For the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib; pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor therapy |
Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.
*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.
To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.