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  1. Drug and Biologic Approval and IND Activity Reports

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 2021*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
21 214391 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Ajanta Pharma Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
20 214387 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Aurobindo Pharma Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
19 214384 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Sun Pharmaceutical Industries Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
18 214017 Droxidopa Capsules, 100 mg, 200 mg, 300 mg ScieGen Pharmaceuticals, Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
17 213911 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Alkem Laboratories Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
16 213661 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Tasman Pharma Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
15 213162 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Teva Pharmaceuticals USA, Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
14 212835 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Hikma Pharmaceuticals USA Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
13 211818 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Zydus Pharmaceuticals (USA) Inc. Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
12 211741 Droxidopa Capsules, 100 mg, 200 mg, 300 mg MSN Laboratories Private Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
11 211726 Droxidopa Capsules, 300 mg Annora Pharma Private Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
10 211652 Droxidopa Capsules, 100 mg, 200 mg, 300 mg Lupin Limited Northera (Droxidopa) Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 For the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension
9 211819 Apremilast Tablets, 10 mg, 20 mg and 30 mg Unichem Laboratories Limited Otezla (Apremilast) Tablets, 10 mg, 20 mg and 30 mg 2/18/2021 For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
8 212080 Loteprednol Etabonate Ophthalmic Gel, 0.5% Akorn Operating Company LLC Lotemax (Loteprednol) Etabonate Ophthalmic Gel, 0.5% 2/10/2021 For the treatment of post-operative inflammation and pain following ocular surgery
7 209564 Linaclotide Capsules, 145 mcg and 290 mcg Mylan Pharmaceuticals Inc. Linzess (Linaclotide) Capsules, 145 mcg and 290 mcg 2/9/2021 For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation
6 210278 Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg Glenmark Pharmaceuticals Inc., USA Qudexy XR (Topiramate Extended-Release) Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg 2/1/2021 For the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older; preventive treatment of migraine in patients 12 years of age and older
5 205971 Imiquimod Cream USP, 3.75% Taro Pharmaceutical Industries Limited Zyclara (Imiquimod) Cream, 3.75% 1/26/2021 For the topical treatment of clinically typical, visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults; for the topical treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older 
4 214235 Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial Caplin Steriles Limited Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial 1/21/2021 For the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia; as an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention 
3 210473 Epoprostenol for Injection, 0.5 mg/Vial and 1.5 mg/Vial Sun Pharmaceutical Industries Limited Veletri (Epoprostenol for Injection), 0.5 mg/Vial and 1.5 mg/Vial 1/15/2021 For the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity
2 206604 Ferumoxytol Injection, 510 mg Iron/17 mL (30 mg/mL) Single-Dose Vials Sandoz Inc. Feraheme (Ferumoxytol) Injection, 510 mg Iron/17 mL (30 mg/mL) Single-Dose Vials 1/15/2021 For the treatment of iron deficiency anemia in adult patients who: have intolerance to oral iron or have had unsatisfactory response to oral iron; or who have chronic kidney disease 
1 213256 Levothyroxine Sodium Capsules, 88 mcg, 100 mcg, and 125 mcg Teva Pharmaceuticals USA, Inc.  Tirosint (Levothyroxine Sodium) Capsules, 88 mcg, 100 mcg, and 125 mcg 1/6/2021 For adults and pediatric patients 6 years and older with hypothyroidism

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.

 



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