First-Time Generic Drug Approvals for 2015
January
- Ritonavir Tablets USP 100 mg
Approved: January 15, 2015 - Roxane Laboratories, Inc.
Generic for: Norvir - Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg and 40 mg
Approved: January 26, 2015 - Ivax Pharmaceuticals, Inc.
Generic for: Nexium Delayed-Release Capsules
February
-
Bimatoprost Ophthalmic Solution 0.03%
Approved: February 20, 2015 - Lupin Pharmaceuticals, Inc.
Generic for: Lumigan - Miglitol Tablets 25 mg, 50 mg and 100 mg
Approved: February 24, 2015 - Orient Pharma Co., Ltd.
Generic for: Glyset
March
- Levoleucovorin Calcium Injection 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single Use Vials
Approved: March 9, 2015 - Company: Sandoz, Inc.
Generic for: Fusilev - Darifenacin Hydrobromide Extended Release Tablets 7.5 mg (base) and 15 mg (base)
Approved: March 13, 2015 - Company: Anchen Pharmaceuticals, Inc.
Generic for: Enablex - Tenofovir Disoproxil Fumarate Tablets 300 mg
Approved: March 18, 2015 - Company: Teva Pharmaceuticals USA
Generic for: Viread - Molindone Hydrochloride Tablets 5 mg, 10 mg and 25 mg
Approved: March 23, 2015 - CorePharma
Generic for: Moban - Tolcapone Tablets 100 mg
Approved: March 26, 2015 - Par Pharmaceutical
Generic for: Tasmar
April
- Sildenafil Citrate Intravenous Solution 10 mg (base)/12.5 mL
Approved: April 1, 2015 - Aurobindo Pharma Ltd.
Generic for: Revatio Injection - Triamcinolone Acetonide Topical Spray 0.147 mg/g
Approved: April 13, 2015 - Perrigo Company plc
Generic for: Kenalog Spray - Nebivolol Hydrochloride Tablets 2.5 mg (base), 5 mg (base), 10 mg (base) and 20 mg (base)
Approved: April 16, 2015 - Amerigen Pharmaceuticals, Ltd.
Generic for: Bystolic - Glatiramer Acetate Injection 20 mg/mL, packaged in 1 mL prefilled syringe
Approved: April 16, 2015 - Sandoz, Inc.
Generic for: Copaxone - Fluorouracil Cream 0.5%
Approved: April 20, 2015 - Spear Pharmaceuticals
Generic for: Carac - Vardenafil Hydrochloride Orally Disintegrating Tablets 10 mg
Approved: April 22, 2015 - Watson Laboratories, Inc.
Generic for: Staxyn - Aripiprazole Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
Approved: April 28, 2015 - Torrent Pharma, Inc.
Generic for: Abilify
May
- Alosetron Hydrochloride Tablets 0.5 mg (base) and 1 mg (base)
Approved: May 4, 2015 - Roxane Laboratories, Inc.
Generic for: Lotronex - Linezolid Tablets 600 mg
Approved: May 18, 2015 - Teva Pharmaceuticals USA Inc.
Generic for: Zyvox Tablets - Risedronate Sodium Delayed Release Tablets 35 mg
Approved: May 18, 2015 - Teva Pharmaceuticals USA, Inc. Generic for: Atelvia - Tigecycline Injection 50 mg/vial
Approved: May 27, 2015 - Sandoz Inc.
Generic for: Tygacil - Moxifloxacin Hydrochloride Ophthalmic Solution 0.5% (base)
Approved: May 28, 2015 - Lupin Ltd.
Generic for: Moxeza - Estradiol Vaginal Tablets 10 mcg
Approved: May 29, 2015 - Amneal Pharmaceuticals
Generic for: Vagifem
June
- Zolpidem Tartrate Sublingual Tablets 1.75 mg and 3.5 mg
Approved: June 3, 2015 - Novel Laboratories,Inc.
Generic for: Intermezzo - Linezolid for Oral Suspension 100 mg/5 mL
Approved: June 3, 2015 - Roxane Laboratories, Inc.
Generic for: Zyvox for Oral Suspension - Eptifibatide Injection 75 mg/100 mL
Approved: June 5, 2015 - Teva Pharmaceuticals USA Inc.
Generic for: Integrilin - Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
Approved: June 12, 2015 - Actavis Mid Atlantic LLC
Generic for: Ziana - Gemifloxacin Mesylate Tablets 320 mg (base)
Approved: June 15, 2015 - Orchid Healthcare
Generic for: Factive - Clindamycin Phosphate and Benzyl Peroxide Gel 1.2%/2.5%
Approved: June 19, 2015 - Actavis Laboratories, Inc.
Generic for: Acanya - Ezetimibe Tablets 10 mg
Approved: June 26, 2015 - Glenmark Pharmaceuticals, Ltd.
Generic for: Zetia - Desvenlafaxine Succinate Extended-Release Tablets 50 mg and 100 mg
Approved: June 29, 2015 - Alembic Pharmaceuticals Ltd.; Lupin Pharmaceuticals Inc.; Sandoz Inc.; Mylan Pharmaceuticals Inc.
Generic for: Pristiq
July
- Almotriptan Malate Tablets 6.25 mg (base) and 12.5 mg (base)
Approved: July 7, 2015 - Teva Pharmaceuticals USA Inc.
Generic for: Axert - Travoprost Ophthalmic Solution USP (Ionic Buffered Solution) 0.004%
Approved: July 10, 2015 - Apotex Inc.
Generic for: Travatan Z - Olopatadine Hydrochloride Ophthalmic Solution 0.2% (base)
Approved: July 13, 2015 - Barr Labs Inc.
Generic for: Pataday - Bivalirudin Injection 250 mg/vial
Approved: July 14, 2015 - Hospira Inc.
Generic for: Angiomax - Metformin Hydrochloride and Repaglinide Tablets 500 mg/1 mg and 500 mg/2 mg
Approved: July 15, 2015 - Lupin Pharmaceuticals, Inc.
Generic for: PrandiMet - Linezolid Injection 200 mg/100 mL and 600 mg/300 mL
Approved: July 16, 2015 - Sandoz, Inc.
Generic for: Zyvox Injection - Ethacrynate Sodium for Injection USP, 50 mg/vial
Approved: July 29, 2015 - Par Sterile Products, LLC
Generic for: Edecrin - Omeprazole Magnesium Delayed Release Tablets (OTC) 20.6 mg (20 mg base)
Approved: July 30, 2015 - Perrigo R&D Company
Generic for: Prilosec OTC
August
- Paliperidone Extended Release Tablets 1.5 mg, 3 mg, 6 mg and 9 mg
Approved: August 3, 2015 - Actavis Laboratories FL, Inc.
Generic for: Invega - Testosterone Topical Gel 1.62%
Approved: August 4, 2015 - Perrigo Israel Pharmaceuticals Ltd
Generic for: Androgel - Testosterone Topical Gel 10 mg per pump actuation
Approved: August 5, 2015 - Actavis Laboratories UT, Inc.
Generic for: Fortesta Gel - Tretinoin Gel USP, 0.05%
Approved: August 13, 2015 - Spear Pharmaceuticals
Generic for: Atralin Gel - Tetrabenazine Tablets 12.5 mg and 25 mg
Approved: August 17, 2015 - Sun Pharma Global FZE
Generic for: Xenazine - Hydroxyprogesterone Caproate Injection USP 250 mg/mL (1.25 g/5 mL vials)
Approved: August 24, 2015 - McGuff Pharmaceuticals, Inc.
Generic for: Delalutin Injection - Guaifenesin and Dextromethorphan Hydrobromide Extended Release Tablets 600 mg/30 mg and 1200 mg/60 mg
Approved: August 31, 2015 - Activis Laboratories FL Inc.
Generic for: Mucinex DM
September
- Rivastigmine Transdermal System 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours
Approved: September 3, 2015 - Alvogen Pine Brook, Inc.
Generic for: Exelon Patch - Guaifenesin Extended-Release Tablets 1200 mg
Approved: September 3, 2015 - Actavis Laboratories FL, Inc.
Generic for: Mucinex Maximum Strength - Balsalazide Disodium Tablets 1.1 gram
Approved: September 8, 2015 - Par Pharmaceutical, Inc.
Generic for: Giazo - Fluvasatin Sodium Extended Release Tablets 80 mg
Approved: September 10, 2015 - Mylan Pharmaceuticals Inc.
Generic for: Lescol XL - Clozapine Orally Disintegrating Tablets 25 mg and 100 mg
Approved: September 15, 2015 - Mylan Pharmaceuticals Inc.
Generic for: Fazaclo ODT - Pimozide Tablets USP, 1 mg and 2 mg
Approved: September 28, 2015 - Par Pharmaceutical, Inc.
Generic for: Orap - Adapalene and Bezoyl Peroxide Gel 0.1%/2.5%
Approved: September 30, 2015 - Actavis Mid Atlantic, LLC
Generic for: Epiduo
October
- Palonosetron Hydrochloride Injection 0.25 mg (base)/5 mL and 0.75 mg (base)/1.5 mL
Approved: October 13, 2015 - Teva Pharmaceuticals USA Inc.; Sandoz Inc.
Generic for: Aloxi Injection - Memantine Hydrochloride Oral Solution 2 mg/mL
Approved: October 13, 2015 - Macleods Pharmaceuticals Limited; Silarx Pharmaceuticals, Inc.
Generic for: Namenda Oral Solution - Itraconazole Oral Solution 10 mg/mL
Approved: October 30, 2015 - Amneal Pharmaceuticals
Generic for: Sporanox Oral Solution
November
- Mesalamine Rectal Suppository 1000 mg
Approved: November 24, 2015 - Mylan Pharmaceuticals Inc.
Generic for: Canasa
December
- Imatinib Mesylate Tablets 100 mg (base) and 400 mg (base)
Approved: December 3, 2015 - Sun Pharmaceutical Industries Ltd.
Generic for: Gleevec - Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Approved: December 7, 2015 - USV North America, Inc.; Apotex, Inc.; Novel Laboratories, Inc.; Zach System S.P.A.
Generic for: Patanol Ophthalmic Solution - Fesoterodine Fumarate Extended-Release Tablets 4 mg and 8 mg
Approved: December 10, 2015 - Alkem Laboratories Limited
Generic for: Toviaz - Busulfan Injection 6 mg/mL
Approved: December 22, 2015 - Pharmaforce, Inc.
Generic for: Busulfex - Neostigmine Methylsulfate Injection USP 5 mg/10 mL and 10 mg/10 mL
Approved: December 28, 2015 - Eurohealth International Sarl
Generic for: Bloxiverz