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 2022*
| ANDA Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 38 | 215398 | Bexarotene Gel, 1% | Amneal Pharmaceuticals LLC | Targretin (Bexarotene) Gel | 4/27/2022 | For the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies |
| 37 | 214596 | Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Vials | Cipla Limited | AquaMEPHYTON (Phytonadione) Injection | 4/22/2022 | For the treatment of certain coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity |
| 36 | 212424 | Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Ampules | Cipla Limited | AquaMEPHYTON (Phytonadione) Injection | 4/22/2022 | For the treatment of certain coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity |
| 35 | 213236 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe | Accord Healthcare Inc. | Lexiscan (Regadenoson) Injection | 4/11/2022 | Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress |
| 34 | 213210 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe | Dr. Reddy’s Laboratories Limited | Lexiscan (Regadenoson) Injection | 4/11/2022 | Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress |
| 33 | 212806 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe | Hong Kong King-Friend Industrial Company Limited | Lexiscan (Regadenoson) Injection | 4/11/2022 | Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress |
| 32 | 207604 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe | Apotex Inc. | Lexiscan (Regadenoson) Injection | 4/11/2022 | Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress |
| 31 | 214082 | Cysteine Hydrochloride Injection USP, 500 mg/10 mL (50 mg/mL), Single-dose Vial | Eton Pharmaceuticals, Inc. | Elcys (Cysteine Hydrochloride) Injection | 4/8/2022 | Indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN |
| 30 | 214301 | Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL) | Indoco Remedies Limited | Vimpat (Lacosamide) Injection | 4/7/2022 | For the treatment of partial-onset seizures in patients 4 years of age and older |
| 29 | 215586 | Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg | Ricon Pharma LLC | Bidil (sosorbide Dinitrate and Hydralazine Hydrochloride) Tablets | 4/6/2022 | For the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status |
| 28 | 091087 | Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% | Sandoz Inc. | Combigan (Brimonidine Tartrate and Timolol Maleate) Ophthalmic Solution | 4/4/2022 | For the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP |
| 27 | 209997 | Sodium Phosphates Injection USP, 15 mM P/5 mL (3 mM P/mL), 45 mM P/15 mL (3 mM P/mL) and 150 mM P/50 mL (3 mM P/mL) Single-Dose Vials | Fresenius Kabi USA, LLC | Sodium Phosphates Injection | 3/30/2022 | As a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake |
| 26 | 210332 | Lactated Ringer's and 5% Dextrose Injection, USP, Single-Dose Container | Fresenius Kabi USA, LLC | Lactated Ringer's and 5% Dextrose Injection | 3/28/2022 | For the parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient |
| 25 | 204787 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Hetero Labs Limited | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 24 | 204857 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Amneal Pharmaceuticals Of New York, LLC | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 23 | 204921 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Msn Laboratories Private Limited | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 22 | 205006 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Glenmark Pharmaceuticals Ltd | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 21 | 205031 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Sun Pharmaceutical Industries Limited | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 20 | 208308 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Indoco Remedies Limited | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 19 | 205237 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Sciegen Pharmaceuticals Inc | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 18 | 204974 | Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg | Alembic Pharmaceuticals Limited | Vimpat (lacosamide) Tablets | 3/17/2022 | Treatment of partial-onset seizures in patients 4 years of age and older |
| 17 | 211699 | Breyna (Budesonide and Formoterol Fumarate Dihydrate) Inhalation Aerosol 160/4.5 mcg/actuation and 80/4.5 mcg/actuation | Mylan Pharmaceuticals Inc., a Viatris Company | Symbicort (Budesonide and Formoterol Fumarate Dihydrate) Inhalation Aerosol | 3/15/2022 | For the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema |
| 16 | 206497 | Methylphenidate Transdermal System, 1.1 mg/hr, 1.6 mg/hr, 2.2 mg/hr, and 3.3 mg/hr | Mylan Technologies Inc. | Daytrana Transdermal System | 3/14/2022 | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) |
| 15 | 212472 | Doxylamine Succinate and Pyridoxine Hydrochloride Extended-Release Tablets, 20 mg/20 mg | Actavis Laboratories FL, Inc. | Bonjesta (Doxylamine Succinate and Pyridoxine Hydrochloride) Extended-Release Tablets | 3/1/2022 | For the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management |
| 14 | 212025 | Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use glass cartridge for use with a reusable pen injector (APOKYN Pen) | Sage Chemical, Inc. | Apokyn (Apomorphine) Injection | 2/23/2022 | For the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease |
| 13 | 211582 | Dapagliflozin Tablets, 5 mg and 10 mg | Zydus Pharmaceuticals (USA) Inc. | Farxiga (Dapagliflozin) Tablets | 2/22/2022 | As an adjunct to diet and exercise to improve glycemic control |
| 12 | 206119 | Tolvaptan Tablets, 15 mg and 30 mg | Par Pharmaceutical, Inc. | Samsca (Tolvaptan) Tablets | 2/15/2022 | Treatment of clinically significant hypervolemic and euvolemic hyponatremia including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) |
| 11 | 214982 | Digoxin Tablets USP, 0.0625 mg, 0.125 mg, and 0.25 mg | Aurobindo Pharma Limited | Lanoxin (Digoxin) Tablets | 2/8/2022 | For the treatment of mild to moderate heart failure in adults |
| 10 | 212955 | Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL), Single-Dose Vials | Purdue Pharma L.P. | Revex (Nalmefene) Injection | 2/8/2022 | For the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids; for management of known or suspected opioid overdose |
| 9 | 203347 | Maraviroc Tablets, 150 mg and 300 mg | Hetero Labs Limited, Unit III | Selzentry (Maraviroc) Tablets | 2/7/2022 | For the treatment of only CCR5- tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg |
| 8 | 205894 | Cyclosporine Ophthalmic Emulsion, 0.05% | Mylan Pharmaceuticals Inc. | Restasis) Cyclosporine Ophthalmic Emulsion | 2/2/2022 | To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca |
| 7 | 210876 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 12.5 mg, 25 mg, 37.5 mg and 50 mg | Teva Pharmaceuticals USA, Inc. | Mydayis (Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate)Extended-Release Capsules | 1/31/2022 | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older |
| 6 | 078479 | Brimonidine Tartrate Ophthalmic Solution, 0.15% | Apotex Inc. | Alphagan P (Brimonidine Tartrate) Ophthalmic Solution | 1/31/2022 | For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
| 5 | 211353 | Sofosbuvir Tablets, 400 mg | Teva Pharmaceuticals USA, Inc | Sovaldi (Sofosbuvir) Tablets | 1/27/2022 | For the treatment of adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen |
| 4 | 213212 | Carbidopa, Levodopa and Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg | Rising Pharma Holdings, Inc. | Stalevo (Carbidopa, Levodopa and Entacapone) Tablets | 1/25/2022 | For the treatment of Parkinson's disease |
| 3 | 212759 | Pirfenidone Tablets, 267 mg and 801 mg | Teva Pharmaceuticals, USA, Inc. | Esbriet (Pirfenidone) Tablets | 1/25/2022 | For the treatment of idiopathic pulmonary fibrosis |
| 2 | 212730 | Pirfenidone Tablets, 267 mg and 801 mg | Accord Healthcare Inc. | Esbriet (Pirfenidone) Tablets | 1/25/2022 | For the treatment of idiopathic pulmonary fibrosis |
| 1 | 212569 | Pirfenidone Capsules, 267 mg | Amneal EU, Limited | Esbriet (Pirfenidone) Capsules | 1/3/2022 | For the treatment of idiopathic pulmonary fibrosis |
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.