Drugs

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 2017*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
29 201971 Rasagiline Tablets, 0.5 mg and 1 mg Mylan Pharmaceuticals Inc. Azilect (Rasagiline) Tablets, 0.5 mg and 1 mg  5/15/2017 For the treatment of Parkinson’s disease
28 207238 Diclofenac Sodium Topical Solution, 2% w/w Actavis Laboratories UT, Inc. Pennsaid (Diclofenac Sodium) Topical Solution, 2% w/w 5/15/2017 For treatment of the pain of osteoarthritis of the knee
27 205833 Moxifloxacin Hydrochloride in Sodium Chloride 0.8% Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags  Mylan Laboratories Limited Avelox (Moxifloxacin Hydrochloride in Sodium Chloride 0.8%) Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags  5/5/2017 For the treatment of infections caused by designated, susceptible bacteria
26 204029 Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial  Abon Pharmaceuticals, LLC Clolar (Clofarabine) Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial 5/9/2017 For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
25 090681 Quetiapine Fumarate Extended-Release Tablets, 150 mg, 200 mg, and 300 mg Accord Healthcare Inc.  Seroquel XR (Quetiapine Fumarate) Extended-Release, 150 mg, 200 mg, and 300 mg   5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
24 206260 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg   Pharmadax Inc. Seroquel XR (Quetiapine Fumarate) Extended-Release), 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg  5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
23 090482 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg   Par Pharmaceutical Inc. Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg 5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
22 202939 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg   IntelliPharmaCeutics Corp. Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg 5/9/2017 For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
21  207712 Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 137mcg/50mcg  Apotex Inc. Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray, 137mcg/50mcg 4/28/2017 For treatment of allergic rhinitis
20  208218 Vigabatrin for Oral Solution USP, 500mg per packet  Par Pharmaceutical, Inc. Sabril (Vigabatrin) for Oral Solution USP, 500mg per packet  4/27/2017 For treatment in refractory complex partial seizures as adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments. For treatment of infantile spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss
19  201890 Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg Impax  Laboratories Inc.
 
Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 4/26/2017 For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments
18 202968 Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg Watson Laboratories, Inc. Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 4/26/2017 For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments
17 200909 Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg Dr. Reddys Laboratories International SA Vytorin (Ezetimibe and Simvastatin) Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg 4/26/2017 For use as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments
16 204867 Prednisone Delayed-Release Tablets, 1mg, 2mg, 5mg Actavis Laboratories FL Inc Rayos (Prednisone) Delayed-Release Tablets, 1mg, 2mg, 5mg 4/25/2017 For use as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation. For the treatment of certain endocrine conditions. For palliation of certain neoplastic conditions
15 206084 Ezetimibe and Atorvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg  Watson Laboratories, Inc. Liptruzet (Ezetimibe and Atorvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg 4/26/2017 For use to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia and to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments
14 202294 Dexlansoprazole Delayed-Release Capsules, 60 mg Par Pharmaceutical Inc.    Dexilant (Dexlansoprazole Delayed-Release) Capsules, 60 mg 4/19/2017 For healing of all grades of erosive esophagitis, maintenance of healed EE and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD)
13 208258 Tazarotene Cream, 0.1% Taro Pharmaceuticals USA, Inc. Tazorac and Avage (Tazarotene) Cream, 0.1% 4/3/2017

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

12 204726 Silodosin Capsules, 4 mg, 8 mg Sandoz Inc. Rapaflo (Silodosin) Capsules, 4 mg, 8 mg 3/31/2017 For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
11 205468 Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base)  Nostrum Laboratories, Inc.  Venlafaxine Hydrochloride ER tablet (Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base)) 3/24/2017 For treatment of major depressive disorder and social anxiety disorder  
10 207809 Melphalan Tablets USP, 2 mg Alvogen Malta Operations Ltd.  Alkeran (Melphalan) Tablets, 2 mg 3/22/2017 For palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary
204929 Zileuton Extended-Release Tablets, 600 mg  Pack Pharmaceuticals, LLC Zyflo CR (Zileuton) Extended-Release Tablets, 600 mg 3/17/2017 For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older  
202511 Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces Lupin Inc. Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate) Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces 2/23/2017 For cleansing of the colon in preparation for colonscopy in adults
7 207952 Logilia Ulipristal Acetate, 30 mg Teva Pharmaceuticals USA, Inc.  Ella (Ulipristal Acetate) Tablets, 30 mg  2/13/2017 For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
6 206939 Cefixime for Oral Suspension USP, 500 mg/5 mL Belcher Pharmaceuticals, LLC Suprax (Cefixime) for Oral Suspension, 500 mg/5 mL  2/6/2017 To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension
 5 208328 Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg Amneal Pharmaceuticals LLC Namzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg  1/27/2017 For the treatment of moderate to severe dementia of the Alzheimer’s type
4 206836 Dalfampridine Extended-Release Tablets, 10 mg Actavis Laboratories FL, Inc. Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg  1/23/2017 To improve walking in patients with multiple sclerosis (MS)
3 206811 Dalfampridine Extended-Release Tablets, 10 mg Aurobindo Pharma Limited Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg  1/23/2017 To improve walking in patients with multiple sclerosis (MS)
2  202090 Sodium Oxybate Oral Solution, 500 mg/mL Roxane Laboratories, Inc. Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL  1/17/2017 For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy
1  207160 Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL Aurobindo Pharma Limited Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL  1/4/2017 Antiepileptic drug indicated for adjunct therapy in adults (≥16 years of age) with certain seizure types when oral administration is temporarily not feasible

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.

Page Last Updated: 05/18/2017
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