First-Time Generic Drug Approvals for 2013
January
- Glimepiride and Pioglitazone Hydrochloride Tablets 2 mg/30 mg and 4 mg/30 mg
Approved: January 4, 2013 - Sandoz Inc.
Generic for: Duetact - Betamethasone Dipropionate and Calcipotriene Ointment 0.064% / 0.005%
Approved: January 14, 2013 - Tolmar, Inc.
Generic for: Taclonex Ointment - Morphine Sulfate Extended-Release Capsules USP, 30 mg, 45 mg, 60 mg, 75 mg, 90 mg and 120 mg
Approved: January 16, 2013 - Actavis Elizabeth, LLC
Generic for: Avinza Extended-Release Capsules - Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Approved: January 18, 2013 - Dr. Reddy's Laboratories Limited
Generic for: Children's Allegra Allergy & Allegra Hives - Mupirocin Cream 2% (base)
Approved: January 24, 2013 - Glenmark Generics Inc., USA
Generic for: Bactroban Cream - Naphazoline Hydrochloride and Pheniramine Maleate Ophthalmic Solution USP 0.025%/0.3% (OTC)
Approved: January 24, 2013 -Akorn Inc.
Generic for: Visine-A Ophthamlic Solution - Rosiglitazone Maleate Tablets 2 mg (base), 4 mg (base) and 8 mg (base)
Approved: January 25, 2013 - Teva Pharmaceuticals USA Inc.
Generic for: Avandia
February
- Doxorubicin Hydrochloride Liposomal Injection 20 mg/10 mL and 50 mg/25 mL
Approved: February 4, 2013 - Sun Pharmaceutical Industries Ltd.
Generic for: Doxil - Mafenide Acetate Topical Solution 5%
Approved: February 12, 2013 - Par Pharmaceutical, Inc.
Generic for: Sulfamylon - Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets 2 mg (base)/0.5 mg (base) and 8 mg (base)/2 mg (base)
Approved: February 22, 2013 - Actavis Elizabeth LLC; Amneal Pharmaceuticals
Generic for: Suboxone Tablets - Alendronate Sodium Oral Solution 70 mg (base)/75 mL (Once Weekly)
Approved: February 25, 2013 - Roxane Laboratories, Inc.
Generic for: Fosamax Oral Solution - Dexbrompheniramine Maleate and Pseudoephedrine Sulfate Extended-Release Tablets (OTC), 6 mg/120 mg
Approved: February 27, 2013 - Avanthi Inc.
Generic for: Drixoral Cold and Allergy Tablets
March
- Travoprost Ophthalmic Solution/Drops 0.004%
Approved: March 1, 2013 - Par Pharmaceutical, Inc.
Generic for: Travatan - Zoledronic Acid Injection 4 mg (base)/5 mL
Approved: March 4, 2013 - Sun Pharma Global FZE; Dr. Reddy's Laboratories Inc.; Actavis Inc.; Agila Specialties Private Limited
Generic for: Zometa - Desvenlafaxine Extended-Release Tablets 50 mg and 100 mg
Approved: March 4, 2013 - Ranbaxy Pharmaceuticals Inc.
Generic for: Pristiq - Fluvoxamine Maleate Extended-Release Capsules 100 mg and 150 mg
Approved: March 13, 2013 - Anchen Pharmaceuticals, Inc.
Generic for: Luvox CR Capsules - Esomeprazole Sodium for Injection 20 mg and 40 mg; single-use vials
Approved: March 18, 2013 - Sun Pharma Global FZE
Generic for: Nexium I.V. For Injection - Mecamylamine Hydrochloride Tablets 2.5 mg
Approved: March 19, 2013 - Nexgen Pharma, Inc.
Generic for: Inversine - Sodium Phenylbutyrate Powder 3 grams/teaspoonful; 250 grams/bottle
Approved: March 22, 2013 - Sigmapharm Laboratories, LLC
Generic for: Buphenyl Powder - Fenofibric Acid Delayed-Release Capsules 45 mg and 135 mg
Approved: March 25, 2013 - Mylan Pharmaceuticals, Inc.
Generic for: Trilipix Delayed-Release Capsules - Amlodipine Besylate and Valsartan Tablets 5 mg (base)/160 mg, 5 mg (base)/320mg, 10 mg (base)/160 mg and 10 mg (base)/320 mg
Approved: March 28, 2013 - Par Pharmaceutical, Inc.
Generic for: Exforge - Zoledronic Acid Injection 5 mg (base)/100 mL (0.05 mg (base)/mL); single-use vials for I.V. administration
Approved: March 29, 2013 - Emcure Pharmaceuticals Ltd.; Dr. Reddy's Laboratories Limited
Generic for: Reclast Injection
April
- Acyclovir Ointment 5%
Approved: April 3, 2013 - Mylan Pharmaceuticals Inc.
Generic for: Zovirax Ointment - Acitretin Capsules 10 mg, 17.5 mg, 22.5 mg and 25 mg
Approved: April 4, 2013 - Barr Laboratories Inc.; Teva Pharmaceuticals USA Inc.
Generic for: Soriatane - Prednisolone Sodium Phosphate Orally Disintegrating Tablets 10 mg (base), 15 mg (base) and 30 mg (base)
Approved: April 10, 2013 - Mylan Pharmaceuticals, Inc.
Generic for: Orapred ODT - Omeprazole and Sodium Bicarbonate for Oral Suspension 20 mg/1680 mg per unit-dose packet and 40 mg/1680 mg per unit-dose packet
Approved: April 19, 2013 - Par Pharmaceutical Inc.
Generic for: Zegerid Powder for Oral Suspension
May
- Candesartan Cilexetil Tablets 4 mg, 8 mg, 16 mg and 32 mg
Approved: May 3, 2013 - Sandoz Inc.
Generic for: Atacand - Zolmitriptan Tablets 2.5 mg and 5 mg
Approved: May 15, 2013 - Apotex Corp.; Glenmark Generics; Mylan Pharmaceuticals, Inc.
Generic for: Zomig Tablets - Zolmitriptan Orally Disintegrating Tablets 2.5 mg and 5 mg
Approved: May 15, 2013 - Apotex Corp.; Glenmark Generics
Generic for: Zomig-ZMT Tablets - Voriconazole for Suspension 200 mg/5 mL
Approved: May 28, 2013 - Mylan Pharmaceuticals Inc.
Generic for: Vfend for Oral Suspension
June
- Riluzole Tablets 50 mg
Approved: June 18, 2013 - Apotex, Inc.; Glenmark Generics Limited; Sun Pharmaceutical Industries Ltd.
Generic for: Rilutek
July
- Rasagiline Mesylate Tablets 0.5 mg and 1 mg
Approved: July 1, 2013 - Watson Laboratories, Inc.
Generic for: Azilect - Decitabine for Injection 50 mg
Approved: July 11, 2013 - Dr. Reddy’s Laboratories Inc.
Generic for: Dacogen - Repaglinide Tablets 1 mg and 2 mg
Approved: July 11, 2013 - Caraco Pharmaceutical Laboratories, Ltd.; Paddock Laboratories, Inc.
Generic for: Prandin - Lamotrigine Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg and 200 mg
Approved: July 15, 2013 - Watson Laboratories, Inc.
Generic for: Lamictal ODT - Acamprosate Calcium Delayed-Release Tablets 333 mg
Approved: July 16, 2013 - Glenmark Generics Inc., USA
Generic for: Campral - Tretinoin Gel USP, (Microspheres) 0.1%
Approved: July 17, 2013 - Spear Pharmaceuticals, Inc.
Generic for: Retin-A Micro - Tretinoin Gel USP, 0.04%
Approved: July 17, 2013 - Spear Pharmaceuticals, Inc.
Generic for: Retin-A Micro Gel - Fenofibric Acid Delayed-Release Capsules 45 mg and 135 mg
Approved: July 18, 2013 - Anchen Pharmaceuticals, Inc.
Generic for: Trilipix Delayed-Release Capsules - Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg
Approved: July 19, 2013 - Lupin Limited
Generic for: Glumetza Tablets
August
- Ethinyl Estradiol and Norethindrone Tablets USP, 0.05 mg/1 mg
Approved: August 8, 2013 - Famy Care Ltd.
Generic for: Ovcon-50 - Dexmethylphenidate Hydrochloride Extended-Release Capsules 30 mg
Approved: August 28, 2013 - Mylan Pharmaceuticals, Inc.
Generic for: Focalin XR - Gatifloxacin Ophthalmic Solution 0.5%
Approved: August 28, 2013 - Lupin Ltd.
Generic for: Zymaxid - Adefovir Dipivoxil Tablets 10 mg
Approved: August 29, 2013 - Sigmapharm Labs LLC
Generic for: Hepsera - Amoxicillin, Clarithromycin and Lansoprazole Capsules/Tablets/Capsules 500 mg/500 mg/30 mg
Approved: August 30, 2013 - Teva Pharmaceuticals USA Inc.
Generic for: Prevpac
September
- Azacitidine Injection 100 mg/vial
Approved: September 16, 2013 - Dr. Reddy's Laboratories, Ltd.
Generic for: Vidaza - Capecitabine Tablets 150 mg and 500 mg
Approved: September 16, 2013 - Teva Pharmaceuticals USA
Generic for: Xeloda - Nitroglycerin Lingual Spray 400 mcg/spray; Packaged in 60 and 200 Metered Spray Containers
Approved: September 20, 2013 - Perrigo Israel Pharmaceuticals, Ltd.
Generic for: Nitrolingual - Paricalcitol Capsules 1 mcg, 2 mcg and 4 mcg
Approved: September 27, 2013 - Teva Pharmaceuticals USA
Generic for: Zemplar Capsules - Esomeprazole Magnesium and Naproxen Delayed Release Tablets 20 mg (base)/375 mg and 20 mg (base)/500 mg
Approved: September 27, 2013 - Dr. Reddy's Laboratories, Ltd.
Generic for: Vimovo - Clonidine Hydrochloride Extended Release Tablets 0.1 mg and 0.2 mg
Approved: September 30, 2013 - Anchen Pharmaceuticals, Inc.
Generic for: Kapvay
October
- Tobramycin Inhalation Solution 300 mg/5 mL
Approved: October 10, 2013 - Teva Pharmaceuticals USA
Generic for: Tobi - Diclofenac Sodium Topical Gel 3%
Approved: October 28, 2013 - Tolmar, Inc.
Generic for: Solaraze - Tolterodine Tartrate Extended-Release Capsules 2 mg and 4 mg
Approved: October 31, 2014 - Mylan Pharmaceuticals, Inc.
Generic for: Detrol LA
November
- Finasteride Tablets USP, 1 mg
Approved: November 5, 2013 - Actavis Totowa LLC; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Accord Healthcare, Inc.; Aurobindo Pharma Limited
Generic for: Propecia - Rabeprazole Sodium Delayed-Release Tablets 20 mg
Approved: November 8, 2013 - Torrent Pharmaceuticals Limited; Lupin Limited; Mylan Pharmaceuticals Inc.; Teva Pharmaceuticals USA; Kremers Urban Pharmaceuticals, Inc.; Dr. Reddy's Laboratories Limited
Generic for: AcipHex - Dexmethylphenidate Hydrochloride Extended-Release Capsules 5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg
Approved: November 18, 2013 - Intellipharmaceutics Corp.
Generic for: Focalin XR - Dexmethylphenidate Hydrochloride Extended-Release Capsules 25 mg, 30 mg, 35 mg and 40 mg
Approved: November 19, 2013 - Teva Pharmaceuticals USA
Generic for: Focalin XR
December
- Abacavir Sulfate, Lamivudine and Zidovudine Tablets 300 mg (base)/150 mg/300 mg
Approved: December 5, 2013 - Lupin Pharmaceuticals, Inc.
Generic for: Trizivir - Duloxetine Hydrochloride Delayed Release Capsules 20 mg (base), 30 mg (base) and 60 mg (base)
Approved: December 11, 2013 - Lupin Pharmaceuticals, Inc.; Teva Pharmaceuticals USA Inc.; Torrent Pharmaceuticals Limited; Sun Pharma Global FZE; Dr. Reddy's Laboratories Limited; Aurobindo Pharma Limited
Generic for: Cymbalta - Diclofenac Sodium Topical Solution 1.5% (w/w)
Approved: December 26, 2013 - Paddock Laboratories LLC
Generic for: Pennsaid Topical Solution - Dexlansoprazole Delayed-Release Capsules 60 mg
Approved: December 26, 2013 - Par Pharmaceutical, Inc.
Generic for: Dexilant