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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+
58 201785 Varenicline Tablets, 0.5 mg and 1 mg Par Pharmaceutical, Inc. Chantix (Varenicline) Tablets, 0.5 mg and 1 mg 8/11/2021 For use as an aid to smoking cessation treatment
57 212348 Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection USP, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) in Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride in 5% Dextrose & 0.225% Sodium Chloride Injection USP, 10 mEq/500 mL (1.49 mg/mL) and 20 mEq/1000 mL (1.49 mg/mL) 7/30/2021 For the treatmentpatients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride
56 212868 Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe Accord Healthcare Inc. Atropine Sulfate Injection USP, 0.25 mg/5 mL, 0.5 mg/5 mL, 1 mg/10mL 7/26/2021 For the temporary blockade of severe or life threatening muscarinic effects
55 211149 Paliperidone Palmitate Extended-Release Injectable Suspension, 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL Teva Pharmaceuticals USA, Inc. Invega Sustenna (Paliperidone Palmitate) Extended-Release Injectable Suspension, 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL 7/6/2021 For the treatment of schizophrenia in adults; schizoaffective disorder in adults
54 211238 Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, 800 mg Dr. Reddy's Laboratories Inc. Aptiom (Eslicarbazepine Acetate) Tablets, 200 mg, 400 mg, 600 mg, 800 mg 6/29/2021 For the adjunctive treatment of partial-onset seizures
53 213762 Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials Axar Pharmaceuticals, Inc. Brovana (Arformoterol Tartrate) Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials 6/22/2021 For the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema
52 213132 Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials Glenmark Pharmaceuticals Limited Brovana (Arformoterol Tartrate) Inhalation Solution, 15 mcg/2 mL, Unit- Dose Vials 6/22/2021 For the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema
51 207306 Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL Single-Dose Vial Cipla USA, Inc. Perforomist (Formoterol Fumarate) Inhalation Solution, 20 mcg/2 mL Single-Dose Vial 6/22/2021 For the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema
50 091141 Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL Single-Dose Vial Teva Pharmaceuticals USA, Inc. Perforomist (Formoterol Fumarate) Inhalation Solution, 20 mcg/2 mL Single-Dose Vial 6/22/2021 For the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema
49 214196 Etravirine Tablets, 25 mg, 100 mg, and 200 mg Amneal EU, Limited Intelence (Etravirine) Tablets, 25 mg, 100 mg, and 200 mg 6/14/2021 For the treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older
48 209330 Carfilzomib for Injection, 10 mg, 30 mg, and 60 mg Single-Dose Vials Breckenridge Pharmaceutical, Inc. Kyprolis (Carfilzomib) for Injection, 10 mg, 30 mg, and 60 mg Single-Dose Vials 6/11/2021 For the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone
47 091677 Lopinavir and Ritonavir Tablets USP, 100 mg/25 mg, 200 mg/50 mg Hetero Labs Limited Kaletra (Lopinavir and Ritonavir) Tablets, 100 mg/25 mg and 200 mg/50 mg 6/4/2021 For the treatment of HIV-1 infection in adults and pediatric patients (14 days and older)
46 212943 Tofacitinib Tablets, 10 mg Ajanta Pharma Limited Xeljanz (Tofacitinib) Tablets, 10 mg 6/1/2021 For the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis,  moderately to severely active ulcerative colitis, and active polyarticular course juvenile idiopathic arthritis
 
45 212007 Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials  Exela Pharma Sciences, LLC. Zinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials 5/21/2021 For use as a supplement to intravenous solutions given for total parenteral nutrition (TPN)
44 201452 Lenalidomide Capsules, 5 mg, 10 mg, 15 mg and 25 mg Natco Pharma Limited Revlimid (Lenalidomide) Capsules, 5 mg, 10 mg, 15 mg and 25 mg 5/21/2021 For the treatment of multiple myeloma; transfusion-dependent anemia; mantle cell lymphoma; previously treated follicular lymphoma; previously treated marginal zone lymphoma
43 212416 Calcitonin Salmon Injection USP, 400 USP units per 2 mL (200 USP units per mL) Multi-Dose Vial  Custopharm, Inc. Miacalcin (Calcitonin Salmon) Injection USP, 400 USP units per 2 mL (200 USP units per mL) Multi-Dose Vial 5/14/2021 Treatment of symptomatic Paget’s disease; hypercalcemia; postmenopausal osteoporosis 
42 209614 Enzalutamide Capsules, 40 mg  Actavis Laboratories FL, Inc Xtandi (Enzalutamide) Capsules, 40 mg 5/14/2021 For the treatment of patients with castration-resistant prostate cancer
41 214805 Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials  Milla Pharmaceuticals, Inc. Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials 5/4/2021 Indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake
40 212248 23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) Single Dose Vial Fresenius Kabi USA, LLC  23.4% Sodium Chloride Injection USP, 120 mEq/30 mL (4 mEq/mL) 4/28/2021 Additive in parenteral fluid therapy for use in patients who have special problem of sodium electrolyte intake or excretion
39 212070 Sodium Chloride Injection, USP, 14.6% 50 mEq/20 mL and 100 mEq/40 mL  Fresenius Kabi USA, LLC Sodium Chloride Injection, USP 14.6% 50 mEq/20 mL and 100 mEq/40 mL 4/28/2021 For the parenteral restoration of sodium ion in patients with restricted oral intake
38 214326 Tiopronin Tablets, 100 mg Teva Pharmaceuticals USA, Inc Thiola (Tiopronin) Tablets, 100 mg 4/26/2021 For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone
37 213313 Pregabalin Extended-Release Tablets, 165 mg, 330 mg Apotex Lyrica CR (Pregabalin) Extended-Release Tablets, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia
36 213226 Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg MSN Laboratories Private Limited Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia
35 211948 Pregabalin Extended-Release Tablets, 82.5 mg Mylan Pharmaceuticals Inc. Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia
34 211889 Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg Sun Pharmaceutical Industries Limited Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia
33 211593 Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg Alvogen Pine Brook LLC Lyrica CR (Pregabalin) Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg 4/13/2021 For the management of neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia
32 206888 Tirofiban Hydrochloride Injection, 12.5 mg/250 mL (50 mcg/mL) Single-Dose Container Gland Pharma Limited Aggrastat (Tirofiban Hydrochloride) Injection, 12.5 mg/250 mL (50 mcg/mL) 4/8/2021 For the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy
31 211224 Macitentan Tablets, 10 mg Zydus Worldwide DMCC Opsumit (Macitentan) Tablets, 10 mg 4/6/2021 For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH
30 212296 Deoxycholic Acid Injection, 20 mg/2 mL (10 mg/mL) (Single-Dose Vial) Slayback Pharma LLC Kybella (Deoxycholic Acid) Injection, 20 mg/2 mL (10 mg/mL) 4/2/2021 For improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults
29 211344 Ibrutinib Capsules, 70 mg and 140 mg Zydus Worldwide DMCC Imbruvica (Ibrutinib) Capsules, 70 mg and 140 mg 3/31/2021 For the treatment of adult patients with mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma , Waldenström’s macroglobulinemia, marginal zone lymphoma, or chronic graft versus host disease
28 205063 Isotretinoin Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg Actavis Laboratories FL, Inc. Absorica (Isotretinoin) Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg 3/31/2021 For the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater
27 203451 50% Dextrose Injection USP, 25 g/50 mL (0.5 g/mL), Single-Dose Prefilled Syringes International Medication Systems, Limited 50% Dextrose Injection USP, 25 g/50 mL (0.5 g/mL), Single-Dose Prefilled Syringes 3/26/2021 For the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels and, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements
26 213424 Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial Accord Healthcare Inc. Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial 3/19/2021 For the temporary blockade of severe or life threatening muscarinic effects
25 214727 Potassium Chloride Injection, 10 mEq/100 mL (7.45 mg/mL), 10 mEq/50 mL (14.9 mg/mL), 20 mEq/100 mL (14.9 mg/mL), 20 mEq/50 mL (29.8 mg/mL), and 40 mEq/100 mL (29.8 mg/mL) Single-Dose Containers Nexus Pharmaceuticals Inc. Potassium Chloride Injection, 10 mEq/100 mL, 10 mEq/50 mL, 20 mEq/100 mL, 20 mEq/50 mL, and 40 mEq/100 mL 3/18/2021 For the treatment of potassium deficiency states when oral replacement is not feasible
24 213523 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP, 10 mEq/1000 mL, 20 mEq/1000 mL, 30 mEq/1000 mL, and 40 mEq/1000 mL in Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection , 10 mEq/1000 mL, 20 mEq/1000 mL, 30 mEq/1000 mL, and 40 mEq/1000 mL 3/9/2021 For patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride
23 213445 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP, 20 mEq/1,000 mL and 40 mEq/1,000 mL, Single-Dose Containers Fresenius Kabi USA, LLC Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP, 20 mEq/1,000 mL and 40 mEq/1,000 mL 3/9/2021 For patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride
22 208269 Hydrocodone Bitartrate Extended-Release Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg  Alvogen Pine Brook LLC  Hysingla ER (Hydrocodone Bitartrate Extended-Release) Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg  3/1/2021 For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
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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