First-Time Generic Drug Approvals for 2014
January
- Lamivudine Tablets (HBV) 100 mg
Approved: January 2, 2014 - Hetero Labs Limited; Apotex Corp.
Generic for: Epivir-HBV - Telmisartan Tablets 20 mg, 40 mg and 80 mg
Approved: January 8, 2014 - Watson Laboratories, Inc.
Generic for: Micardis - Amlodipine Besylate and Telmisartan Tablets 5 mg (base)/40 mg, 10 mg (base)/40 mg, 5 mg (base)/80 mg and 10 mg (base)/80 mg
Approved: January 8, 2014 - Lupin Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Inc.
Generic for: Twynsta - Sirolimus Tablets 0.5 mg, 1 mg and 2 mg
Approved: January 8, 2014 - Zydus Pharmaceuticals (USA) Inc.
Generic for: Rapamune - Mycophenolic Acid Delayed-Release Tablets 180 mg and 360 mg
Approved: January 8, 2014 - Mylan Pharmaceuticals, Inc.
Generic for: Myfortic - Doxercalciferol Capsules 1 mcg and 2.5 mcg
Approved: January 14, 2014 - Roxane Laboratories, Inc.
Generic for: Hectorol - Fluocinonide Cream USP, 0.1%
Approved: January 14, 2014 - Perrigo Israel Pharmaceuticals, Ltd.
Generic for: Vanos - Bromfenac Ophthalmic Solution 0.09% (Once-A-Day)
Approved: January 22, 2014 - Hi-Tech Pharmacal Co., Inc.
Generic for: Bromday - Sunitinib Malate Capsules 12.5 mg (base), 25 mg (base), 37.5 mg (base) and 50 mg (base)
Approved: January 30, 2014 - Mylan Pharmaceuticals Inc.
Generic for: Sutent
February
- Pramipexole Dihydrochloride Extended-Release Tablets 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg
Approved: February 6, 2014 - Anchen Pharmaceuticals, Inc.
Generic for: Mirapex ER - Ketorolac Tromethamine Ophthalmic Solution/Drops 0.45%
Approved: February 10, 2014 - Akorn, Inc.
Generic for: Acuvail - Ibandronate Sodium Injection 3 mg (base)/3 mL
Approved: February 14, 2014 - Sun Pharmaceutical Industries Ltd.
Generic for: Boniva Injection - Moxifloxacin Hydrochloride Tablets 400 mg (base)
Approved: February 18, 2014 - Teva Pharmaceuticals USA Inc.
Generic for: Avelox - Rifabutin Capsules 150 mg
Approved: February 24, 2014 - Lupin Pharmaceuticals, Inc.
Generic for: Mycobutin - Hydrochlorothiazide and Telmisartan Tablets 12.5 mg/40 mg, 12.5 mg/80 mg and 25 mg/80 mg
Approved: February 25, 2014 - Mylan Pharmaceuticals Inc.; Torrent Pharmaceuticals Limited; Alembic Pharmaceuticals Limited
Generic for: Micardis HCT - Dutasteride and Tamsulosin Capsules 0.5 mg/0.4 mg
Approved: February 26, 2014 - Anchen Pharmaceuticals, Inc.
Generic for: Jalyn
March
- Raloxifene Hydrochloride Tablets 60 mg
Approved: March 4, 2014 - Teva Pharmaceuticals, Inc.
Generic for: Evista - Oxybutynin Transdermal System 3.9 mg/24 hr
Approved: March 4, 2014 - Barr Laboratories Inc.
Generic for: Oxytrol - Carbidopa Tablets 25 mg
Approved: March 10, 2014 - Amerigen Pharmaceuticals Inc.
Generic for: Lodosyn - Atovaquone Oral Suspension 750 mg/5 mL
Approved: March 18, 2014 - Amneal Pharmaceuticals LLC
Generic for: Mepron Suspension
April
- Solifenacin Succinate Tablets 5 mg and 10 mg
Approved: April 2, 2014 - Teva Pharmaceuticals, Inc.
Generic for: Vesicare - Clonidine Hydrochloride Extended Release Tablets 0.1 mg and 0.2 mg
Approved: April 2, 2014 - Anchen Pharmaceuticals, Inc.
Generic for: Jenloga - Nevirapine Extended Release Tablets 400 mg
Approved: April 3, 2014 - Apotex Inc.; Sandoz Inc. Generic for: Viramune XR - Omega-3-Acid Ethyl Esters Capsules 1 gram
Approved: April 7, 2014 - Teva Pharmaceuticals, Inc.
Generic for: Lovaza - Norelgestromin and Ethinyl Estradiol Transdermal System 150 mcg / 35 mcg (per day)
Approved: April 16, 2014 - Mylan Pharmaceuticals Inc.
Generic for: Ortho Evra - Atazanavir Sulfate Capsules 100 mg (base), 150 mg (base), 200 mg (base) and 300 mg (base)
Approved: April 22, 2014 - Teva Pharmaceuticals, Inc.
Generic for: Reyataz - Norethindrone and Ethinyl Estradiol and Ferrous Fumarate Chewable Tablets 0.8 mg / 0.025 mg
Approved: April 23, 2014 - Famy Care Limited
Generic for: Generess Fe
May
-
Metformin Hydrochloride and Rosiglitazone Maleate Tablets 500 mg/2 mg (base), 500 mg/4 mg (base), 1000 mg/2 mg (base) and 1000 mg/4 mg (base)
Approved: May 7, 2014 - Teva Pharmaceuticals, Inc.
Generic for: Avandamet - Budesonide Nasal Spray 0.032 mg/inhalation
Approved: May 12, 2014 - Apotex, Inc.
Generic for: Rhinocort Aqua - Hydromorphone Hydrochloride Extended Release Tablets 8 mg, 12 mg and 16 mg
Approved: May 12, 2014 - Actavis plc
Generic for: Exalgo - Diclofenac Sodium Topical Solution 1.5%
Approved: May 27, 2014 - Apotex, Inc.
Generic for: Pennsaid - Atovaquone and Proguanil Hydrochloride Tablets 62.5 mg/25 mg and 250 mg/100 mg
Approved: May 27, 2014 - Mylan Pharmaceuticals, Inc.
Generic for: Malarone - Celecoxib Capsules 50 mg, 100 mg, 200 mg and 400 mg
Approved: May 30, 2014 - Teva Pharmaceuticals, Inc.; Mylan Pharmaceuticals, Inc. (50 mg)
Generic for: Celebrex
June
- Risedronate Sodium Tablets 75 mg and 150 mg
Approved: June 10, 2014 - Apotex, Inc.; Mylan Pharmaceuticals, Inc.; Sun Pharma Global FZE
Generic for: Actonel 75 mg and 150 mg - Erlotinib Hydrochloride Tablets 25 mg, 100 mg and 150 mg
Approved: June 11, 2014 - Mylan Pharmaceuticals, Inc.
Generic for: Tarceva - Valsartan Tablets 40 mg, 80 mg, 160 mg and 320 mg
Approved: June 26, 2014 - Ohm Laboratories, Inc.
Generic for: Diovan
August
- Metoclopramide Hydrochloride Orally Disintegrating Tablets 5 mg (base) and 10 mg (base)
Approved: August 12, 2014 - Novel Labs, Inc.
Generic for: Metozolv ODT - Bexarotene Capsules 75 mg
Approved: August 12, 2014 - Banner Pharmacaps
Generic for: Targretin - Dexmedetomidine Hydrochloride Injection 200 mcg (base)/ 2 mL
Approved: August 15, 2014 - Mylan Institutional LLC; Par Pharmaceutical, Inc.
Generic for: Precedex - Entecavir Tablets 0.5 mg and 1 mg
Approved: August 26, 2014 - Teva Pharmaceuticals USA Inc.
Generic for: Baraclude - Frovatriptan Succinate Tablets 2.5 mg (base)
Approved: August 28, 2014 - Mylan Pharmaceuticals Inc.
Generic for: Frova
September
- Moxifloxacin Hydrochloride Ophthalmic Solution 0.5% (base)
Approved: September 4, 2014 - Lupin Pharmaceuticals, Inc.
Generic for: Vigamox - Tacrolimus Topical Ointment 0.03% and 0.1%
Approved: September 9, 2014 - Fougera Pharmaceuticals Inc.
Generic for: Protopic - Daptomycin Injection 500 mg/vial
Approved: September 12, 2014 - Hospira, Inc.
Generic for: Cubicin
October
- Olopatadine Hydrochloride Nasal Spray 0.665 mg/Spray
Approved: October 8, 2014 - Apotex, Inc.
Generic for: Patanase - Ivermectin Tablets 3 mg
Approved: October 27, 2014 - Edenbridge Pharmaceuticals, LLC
Generic for: Stromectol
November
- Valganciclovir Hydrochloride Tablets 450 mg (base)
Approved: November 4, 2014 - Endo Pharmaceuticals Inc.; Dr. Reddy's Laboratories Limited Generic for: Valcyte
December
- Bimatoprost Ophthalmic Solution 0.03%
Approved: December 1, 2014 - Apotex, Inc.
Generic for: Latisse - Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day (Twice-Weekly)
Approved: December 19, 2015 - Mylan Technologies, Inc.
Generic for: Vivelle-Dot - Desvenlafaxine Succinate Extended-Release Tablets 50 mg and 100 mg
Approved: December 31, 2014 - Roxane Laboratories, Inc.
Generic for: Pristiq