First-Time Generic Drug Approvals for 2017
January
- Sodium Oxybate Oral Solution 500 mg/mL
Approved: January 17, 2017 - West-Ward Pharmaceuticals Corp.
Generic for: Xyrem - Desoximetasone Topical Spray 0.25%
Approved: January 20, 2017 - Perrigo Company plc
Generic for: Topicort Spray - Dalfampridine Extended Release Tablets 10mg
Approved: January 23, 2017 - Aurobindo Pharma Limited; Actavis Inc.
Generic for: Ampyra - Donepezil Hydrochloride and Memantine Hydrochloride Extended-Release Capsules 10 mg/ 14 mg and 10 mg/ 28 mg
Approved: January 27, 2017 - Amneal Pharmaceuticals LLC
Generic for: Namzaric
February
- Cefixime for Oral Suspension USP, 500 mg/5 mL
Approved: February 6, 2017 - Belcher Pharmaceuticals, LLC
Generic for: Suprax for Oral Suspension, 500 mg/5 mL - Logilia (Ulipristal Acetate) Tablets 30 mg
Approved: February 13, 2017 - Teva Pharmaceuticals USA, Inc.
Generic for: Ella - Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution 17.5 g/3.13 g/1.6 g per 6 ounces
Approved: February 23, 2017 - Lupin Inc.
Generic for: Suprep Bowel Prep Kit
March
- Zileuton Extended Release Tablets 600 mg
Approved: March 17, 2017 - Pack Pharmaceuticals, LLC
Generic for: Zyflo CR - Melphalan Tablets 2 mg
Approved: March 22, 2017 - Alvogen Malta Operations Ltd.
Generic for: Alkeran Tablets - Silodosin Capsules 4 mg and 8 mg
Approved: March 31, 2017 - Sandoz Inc.
Generic for: Rapaflo
April
- Tazarotene Cream 0.1%
Approved: April 3, 2017 - Taro Pharmaceuticals USA, Inc.
Generic for: Tazorac Cream 0.1% and Avage Cream 0.1% - Dexlansoprazole Delayed-Release Capsules 60mg
Approved: April 19, 2017 - Par Pharmaceutical, Inc.
Generic for: Dexilant - Prednisone Delayed-Release Tablets 1 mg, 2 mg and 5 mg
Approved: April 25, 2017 - Actavis Pharma, Inc.
Generic for: Rayos - Ezetimibe and Simvastatin Tablets 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
Approved: April 26, 2017 - Dr. Reddy's Laboratories Limited; Impax Laboratories, Inc.; Watson Laboratories, Inc.
Generic for: Vytorin - Vigabatrin for Oral Solution 500 mg/packet
Approved: April 27, 2017 - Par Pharmaceutical Inc.
Generic for: Sabril for Oral Solution
May
- Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg
Approved: May 9, 2017 - IntelliPharmaCeutics Corp.; Par Pharmaceutical Inc.; Pharmadax Inc.; Accord Healthcare Inc.
Generic for: Seroquel XR - Clofarabine Injection 20 mg/20 mL Single-Use Vial
Approved: May 9, 2017 - Abon Pharmaceuticals, LLC
Generic for: Clolar - Diclofenac Sodium Topical Solution 2%
Approved: May 15, 2017 - Actavis Laboratories, Inc.
Generic for: Pennsaid - Atomoxetine Hydrochloride Capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
Approved: May 30, 2017 - Apotex Inc.; Teva Pharmaceuticals USA Inc.; Aurobindo Pharma Limited; Glenmark Pharmaceuticals Limited
Generic for: Strattera
June
- Mesalamine Delayed-Release Tablets USP, 1.2 g
Approved: June 5, 2017 - Zydus Pharmaceuticals (USA) Inc.
Generic for: Lialda - Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg
Approved: June 8, 2017 - Teva Pharmaceuticals USA
Generic for: Truvada - Sevelamer Carbonate for Oral Suspension 800 mg/packet and 2.4 g/packet
Approved: June 13, 2017 - Aurobindo Pharma Ltd.
Generic for: Renvela for Oral Suspension - Doxycycline Hyclate Tablets USP, 75 mg and 150 mg
Approved: June 14, 2017 - Mayne Pharma, Inc.
Generic for: Acticlate - Eletriptan Hydrobromide Tablets 20 mg (base) and 40 mg (base)
Approved: June 16, 2017 - Zydus Pharmaceuticals USA, Inc.
Generic for: Relpax - Paroxetine Mesylate Capsules 7.5 mg
Approved: June 20, 2017 - Actavis Laboratories FL, Inc.
Generic for: Brisdelle - Phentermine Hydrochloride Orally Disintegrating Tablets 15 mg, 30 mg and 37.5 mg
Approved: June 28, 2017 - Zydus Pharmaceuticals (USA) Inc.
Generic for: Suprenza
July
- Prasugrel Tablets 5 mg and 10 mg
Approved: July 12, 2017 - Mylan Pharmaceuticals Inc.
Generic for: Effient - Sevelamer Carbonate Tablets 800mg
Approved: July 17, 2017 - Aurobindo Pharma Limited
Generic for: Renvela Tablets - Mesalamine Delayed-Release Tablets USP, 800 mg
Approved: July 21, 2017 - Zydus Pharmaceuticals (USA) Inc.
Generic for: Asacol HD - Minoxidil Topical Aerosol 5% (for Women)
Approved: July 27, 2017 - Watson Laboratories, Inc.
Generic for: Women's Rogaine
August
- Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL single-dose vials
Approved: August 2, 2017 - Nexus Pharmaceuticals, Inc.
Generic for: Isuprel Injection - Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base) and 1 gram (base)
Approved: August 11, 2017 - Natco Pharma Limited
Generic for: Fosrenol Chewable Tablets - Esomeprazole Magnesium Delayed-Release Capsules 20 mg (OTC)
Approved: August 18, 2017 - Perrigo Pharmaceuticals Company
Generic for: Nexium 24HR Capsules (OTC) - Ephedrine Sulfate Injection USP, 50 mg/mL Single-Dose Vial
Approved: August 23, 2017 - Sandoz Inc.
Generic for: Akovaz - Tacrolimus Injection 5mg (base)/mL
Approved: August 25, 2017 - Hospira, Inc.
Generic for: Prograf Injection
September
- Oseltamivir Phosphate for Oral Suspension 6 mg (base)/mL
Approved: September 14, 2017 - Nesher Pharmaceuticals (USA) LLC
Generic for: Tamiflu for Oral Suspension
October
- Glatiramer Acetate Injection 40 mg/mL
Approved: October 3, 2017 - Mylan Pharmaceuticals Inc.
Generic for: Copaxone 40 mg/mL - Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules 20mg/10mg
Approved: October 10, 2017 - Actavis Pharma, Inc.
Generic for: Nuedexta - Dapsone Gel 5%
Approved: October 16, 2017 - Taro Pharmaceuticals USA
Generic for: Aczone - Carvedilol Phosphate Extended Release Capsules 10 mg, 20 mg, 40 mg and 80 mg
Approved: October 25, 2017 - Sun Pharmaceutical Industries Limited
Generic for: Coreg CR
November
- Butenafine Hydrochloride Topical Cream 1% (OTC)
Approved: November 16, 2017 - Taro Pharmaceuticals U.S.A., Inc.
Generic for: Lotrimin Ultra - Darunavir Ethanolate Tablets 600 mg (base)
Approved: November 21, 2017 - Teva Pharmaceuticals USA, Inc.
Generic for: Prezista Tablets 600 mg - Capreomycin Sulfate Injection 1 gram (base) /vial
Approved: November 27, 2017 - Mylan Pharmaceuticals Inc.
Generic for: Capastat Sulfate - Praziquantel Tablets 600mg
Approved: November 27, 2017 - Par Pharmaceutical, Inc.
Generic for: Biltricide
December
- Ibuprofen and Pseudoephedrine Hydrochloride Capsules 200 mg/ 30 mg (OTC)
Approved: December 1, 2017 - Aurobindo Pharma Limited
Generic for: Advil Cold and Sinus Liqu-Gels - Triamcinolone Acetonide Injectable Suspension USP 40 mg/mL vials, 200 mg/5 mL (40 mg/mL) multi-dose vials and 400 mg/10 mL (40 mg/mL) multi-dose vials
Approved: December 13, 2017 - Amneal Pharmaceuticals Company
Generic for: Kenalog-40 Injection
- Efavirenz Capsules 50mg, 100mg and 200mg
Approved: December 15, 2017 - Aurobindo Pharma Limited
Generic for: Sustiva Capsules - Estradiol Vaginal Cream USP, 0.01%
Approved: December 29, 2017 - Mylan Pharmaceuticals Inc.
Generic for: Estrace Vaginal Cream