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 NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
39205927Prasugrel Tablets, 5 mg, 10 mgMylan PharmaceuticalsEffient (Prasugrel) Tablets, 5 mg, 10 mg 7/12/2017A P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in certain patients with acute coronary syndrome who are to be managed with PCI
38204663Phentermine Hydrochloride Orally Disintegrating Tablets,
15 mg, 30 mg,  37.5 mg
Zydus Pharmaceuticals (USA) Inc.Suprenza (Phentermine Hydrochloride) Orally Disintegrating Tablets, 15 mg, 30 mg, 37.5 mg 6/28/2017  
 
For use as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for certain patients
37207139Paroxetine Capsules, 7.5 mgActavis Laboratories FL, Inc.Brisdelle (Paroxetine) Capsules, 7.5 mg6/20/2017For the treatment of moderate to severe vasomotor symptoms associated with menopause
36208765Doxycycline Hyclate Tablets USP, 75 mg, 150 mgMayne Pharma, Inc.Acticlate (Doxycycline Hyclate) Tablets, 75 mg, 150 mg6/14/2017For treatment of rickettsial, sexually transmitted, respiratory tract, ophthalmic, and specific bacterial infections; anthrax, including inhalational anthrax (post-exposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy for acute intestinal amebiasis and severe acne; and prophylaxis of malaria
35207624Sevelamer Carbonate Powder for Oral Suspension, 0.8 g, 2.4 gAurobindo Pharma LimitedRenvela (Sevelamer Carbonate) Powder for Oral Suspension, 0.8 g, 2.4 g6/13/2017 For the control of serum phosphorus in adults with chronic kidney disease on dialysis
34090894Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg Teva Pharmaceuticals USATruvada (Emtricitabine and Tenofovir Disoproxil Fumarate) Tablets, 200 mg/300 mg6/8/2017For the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. For treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg
33091640Mesalamine Delayed-Release Tablets USP, 1.2 gZydus Pharmaceuticals (USA) Inc.Lialda (Mesalamine) Delayed-Release Tablets USP, 1.2 g6/5/2017 For the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis 
3279019Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Glenmark Pharmaceuticals Limited Strattera (Atomoxetine) Capsules USP,10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
3179016Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Aurobindo Pharma LimitedStrattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
3079022Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mgTeva Pharmaceuticals USAStrattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
2978983Atomoxetine Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mgApotex, Inc.Strattera (Atomoxetine) Capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg 5/30/2017For the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD)
28077337Rosiglitazone Maleate and Metformin Hydrochloride Tablets, 1 mg (base)/500 mgTeva PharmaceuticalsAvandamet (Rosiglitazone Maleate and Metformin Hydrochloride) Tablets, 1 mg (base)/500 mg5/19/2017For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
27204029Moxifloxacin Hydrochloride in Sodium Chloride 0.8% Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags Mylan Laboratories LimitedAvelox (Moxifloxacin Hydrochloride in Sodium Chloride 0.8%) Solution, 400 mg/250 mL (1.6 mg/mL) in 250 mL single-dose flexible bags 5/5/2017For the treatment of infections caused by designated, susceptible bacteria
26090681Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial Abon Pharmaceuticals, LLCClolar (Clofarabine) Injection, 20 mg/20 mL (1 mg/mL) Single-Use Vial5/9/2017For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
25206260Quetiapine Fumarate Extended-Release Tablets, 150 mg, 200 mg, 300 mgAccord Healthcare Inc. Seroquel XR (Quetiapine Fumarate) Extended-Release, 150 mg, 200 mg, 300 mg  5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
24090482Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg  Pharmadax Inc.Seroquel XR (Quetiapine Fumarate) Extended-Release), 50 mg, 150 mg, 200 mg, 300 mg, 400 mg 5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
23202939Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg  Par Pharmaceutical Inc.Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
22205833Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg  IntelliPharmaCeutics Corp.Seroquel XR (Quetiapine Fumarate) Extended-Release, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg5/9/2017For the treatment of schizophrenia; bipolar I disorder, manic or mixed episodes; bipolar disorder, depressive episodes; and major depressive disorder, adjunctive therapy with antidepressants
21207712Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 137mcg/50mcg Apotex Inc.Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray, 137mcg/50mcg4/28/2017For treatment of allergic rhinitis
20 208218Vigabatrin for Oral Solution USP, 500mg per packet Par Pharmaceutical, Inc.Sabril (Vigabatrin) for Oral Solution USP, 500mg per packet 4/27/2017For 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 201890Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mgImpax  Laboratories Inc.
 
Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg4/26/2017For 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
18202968Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mgWatson Laboratories, Inc.Vytorin (Ezetimibe and Simvastatin), 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg4/26/2017For 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
17200909Ezetimibe and Simvastatin Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mgDr. Reddys Laboratories International SAVytorin (Ezetimibe and Simvastatin) Tablets, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg4/26/2017For 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
16206084Ezetimibe 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 mg4/26/2017For 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
15204867Prednisone Delayed-Release Tablets, 1mg, 2mg, 5mgActavis Laboratories FL IncRayos (Prednisone) Delayed-Release Tablets, 1mg, 2mg, 5mg4/25/2017For 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
14202294Dexlansoprazole Delayed-Release Capsules, 60 mgPar Pharmaceutical Inc.   Dexilant (Dexlansoprazole Delayed-Release) Capsules, 60 mg4/19/2017For 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)
13208258Tazarotene 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

12204726Silodosin Capsules, 4 mg, 8 mgSandoz Inc.Rapaflo (Silodosin) Capsules, 4 mg, 8 mg3/31/2017For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
11205468Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base) Nostrum Laboratories, Inc. Venlafaxine Hydrochloride ER tablet (Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base))3/24/2017For treatment of major depressive disorder and social anxiety disorder  
10207809Melphalan Tablets USP, 2 mgAlvogen Malta Operations Ltd. Alkeran (Melphalan) Tablets, 2 mg3/22/2017For palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary
204929Zileuton Extended-Release Tablets, 600 mg Pack Pharmaceuticals, LLCZyflo CR (Zileuton) Extended-Release Tablets, 600 mg3/17/2017For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older  
202511Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ouncesLupin 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 ounces2/23/2017For cleansing of the colon in preparation for colonscopy in adults
7207952Logilia Ulipristal Acetate, 30 mgTeva Pharmaceuticals USA, Inc. Ella (Ulipristal Acetate) Tablets, 30 mg 2/13/2017For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
6206939Cefixime for Oral Suspension USP, 500 mg/5 mLBelcher Pharmaceuticals, LLCSuprax (Cefixime) for Oral Suspension, 500 mg/5 mL 2/6/2017To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension
 5208328Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mgAmneal Pharmaceuticals LLCNamzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg 1/27/2017For the treatment of moderate to severe dementia of the Alzheimer’s type
4206836Dalfampridine Extended-Release Tablets, 10 mgActavis Laboratories FL, Inc.Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg 1/23/2017To improve walking in patients with multiple sclerosis (MS)
3206811Dalfampridine Extended-Release Tablets, 10 mgAurobindo Pharma LimitedAmpyra (Dalfampridine) Extended-Release Tablets, 10 mg 1/23/2017To improve walking in patients with multiple sclerosis (MS)
2 202090Sodium Oxybate Oral Solution, 500 mg/mLRoxane Laboratories, Inc.Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL 1/17/2017For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy
1 207160Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mLAurobindo Pharma LimitedLevetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL 1/4/2017Antiepileptic 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: 07/14/2017
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