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+ | |
|---|---|---|---|---|---|---|
| 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.