First-Time Generic Drug Approvals for 2012
January
- Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution
Approved: January 25, 2012 - Novel Laboratories, Inc.
Generic for: Moviprep For Oral Solution
February
- Cisatracurium Besylate Injection 2 mg (base)/mL; packaged in 20 mg (base)/10 mL multiple-dose vials
Approved: February 3, 2012 - Sandoz Inc.
Generic for: Nimbex Injection - Cisatracurium Besylate Injection (Preservative Free) 10 mg (base)/mL packaged in 200 mg (base)/20 mL; and 2 mg (base)/mL packaged in 100 mg (base)/5 mL single-dose vials
Approved: February 3, 2012 - Sandoz Inc.
Generic for: Nimbex Injection - Tizanidine Hydrochloride Capsules 2 mg (base), 4 mg (base) and 6 mg (base)
Approved: February 3, 2012 - Apotex Inc.
Generic for: Zanaflex Capsules - Doxycycline Hyclate Delayed-Release Tablets USP, 150 mg (base)
Approved: February 8, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Doryx Delayed-Release Tablets
Progesterone Capsules 100 mg and 200 mg
Approved: February 29, 2012 - Teva Pharmaceuticals USA
Generic for: Prometrium Capsules
March
- Fenofibrate Capsules 43 mg and 130 mg
Approved: March 1, 2012 - Dr Reddy's Laboratories, S.A.
Generic for: Antara - Ziprasidone Hydrochloride Tablets 20 mg (base), 40 mg (base), 60 mg (base) and 80 mg (base)
Approved: March 2, 2012 - Lupin Pharmaceuticals, Inc.; Apotex Corp.; Dr. Reddy's Laboratories Limited
Generic for: Geodon - Glycopyrrolate Tablets USP, 1.5 mg
Approved: March 12, 2012 - Nexgen Pharma, Inc.
Generic for: Robinul Forte - Escitalopram Oxalate Tablets 5 mg (base), 10 mg (base) and 20 mg (base)
Approved: March 14, 2012 - Teva Pharmaceuticals, USA
Generic for: Lexapro Tablets - Escitalopram Oxalate Oral Solution 5 mg (base)/5 mL
Approved: March 14, 2012 - Amneal Pharmaceuticals LLC
Generic for: Lexapro Oral Solution - Ibandronate Sodium Tablets 150 mg (base)
Approved: March 19, 2012 - Apotex Inc.; Mylan Pharmaceuticals Inc.; Orchid Healthcare
Generic for: Boniva - Quetiapine Fumarate Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), 200 mg (base), 300 mg (base) and 400 mg (base)
Approved: March 27, 2012 - Dr. Reddy's Laboratories Limited; Teva Pharmaceuticals, USA; Roxane Laboratories, Inc.; Mylan Pharmaceuticals Inc.; Apotex Corp.; Aurobindo Pharma Limited; Torrent Pharmaceuticals Limited; Lupin Pharmaceuticals Inc.; Sun Pharmaceutical Industries; Accord Healthcare Inc.
Generic for: Seroquel - Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg
Approved: March 30, 2012 - Teva Pharmaceuticals USA
Generic for: Avalide - Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg
Approved: March 30, 2012 - Teva Pharmaceuticals USA
Generic for: Avapro
April
- Vancomycin Hydrochloride Capsules 125 mg (base) and 250 mg (base)
Approved: April 9, 2012 - Akorn,Inc.; Strides Arcolab Ltd.; Watson Laboratories, Inc.
Generic for: Vancocin Capsules - Fluvastatin Sodium Capsules 20 mg (base) and 40 mg (base)
Approved - April 11, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Lescol - Tinidazole Tablets 250 mg and 500 mg
Approved: April 30, 2012 - Roxane Laboratories, Inc., Novel Labs, Inc.
Generic for: Tindamax
May
- Vardenafil Tablets 2.5 mg, 5 mg, 10 mg and 20 mg
Approved: May 3, 2012 - Teva Pharmaceuticals USA
Generic for: Levitra - Carbidopa, Entacapone and Levodopa Tablets 25 mg/200 mg/100 mg and 37.5 mg/200 mg/150 mg
Approved: May 10, 2012 - Sun Pharma Global FZE
Generic for: Stalevo 100 and Stalevo 150 - Clopidogrel Tablets 75 mg (base) and 300 mg (base)
Approved: May 17, 2012 - Apotex Inc.; Aurobindo Pharma Limited; Dr.Reddy's Laboratories Limited; Gate Pharmaceuticals; Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Sun Pharma Global FZE; Teva Pharmaceuticals, USA Inc.; Torrent Pharmaceuticals Limited
Generic for: Plavix - Ropinirole Hydrochloride Extended-Release 2 mg (base), 4 mg (base), 6 mg (base), 8 mg (base) and 12 mg (base)
Approved: May 17, 2012 - Actavis Elizabeth LLC
Generic for: Requip XL - Butoconazole Vaginal Cream 2%
Approved: May 18, 2012 - Perrigo Israel
Generic for: Gynazole-1 - Minocycline Hydrochloride Extended-Release Tablets 65 mg (base) and 115 mg (base)
Approved: May 18, 2012 - Barr Laboratories, Inc.
Generic for: Solodyn - Lansoprazole Delayed-Release Capsules 15 mg (OTC)
Approved: May 18, 2012 - Dr.Reddy's Laboratories Limited; Perrigo; Wockhardt Ltd.
Generic for: Prevacid 24HR - Nevirapine Tablets 200 mg
Approved: May 22, 2012 - Apotex Corp.; Aurobindo Pharma Limited; Camber Pharmaceuticals, Inc.; Cipla Limited; Micro Labs Limited; Mylan Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Sciegen Pharmaceuticals
Generic for: Viramune Tablets - Nevirapine Oral Suspension 50 mg/5 mL
Approved: May 22, 2012 - Aurobindo Pharma Limited
Generic for: Viramune Oral Suspension - Dextromethorphan Polistirex Extended Release Suspension eq 30 mg dextromethorphan hydrobromide /5 mL
Approved: May 25, 2012 - Tris Pharma, Inc.
Generic for: Delsym 12 Hour Cough Relief - Voriconazole for Injection 200 mg/vial
Approved: May 30, 2012 - Sandoz, Inc.
Generic for: Vfend I.V. - Calcipotriene Cream 0.005%
Approved: May 30, 2012 - Tolmar, Inc.
Generic for: Dovonex Cream
June
- Armodafinil Tablets 50 mg, 150 mg and 250 mg
Approved: June 1, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Nuvigil - Adapalene Gel 0.3%
Approved: June 14, 2012 - Tolmar, Inc.
Generic for: Differin Gel 0.3% - Abacavir Sulfate Tablets 300 mg (base)
Approved: June 18, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Ziagen - Olanzapine and Fluoxetine Hydrochloride Capsules 25 mg (base)/6 mg (base), 25 mg (base)/12 mg (base), 50 mg (base)/6 mg (base) and 50 mg (base)/12 mg (base)
Approved: June 19, 2012 - Teva Pharmaceuticals USA Inc.
Generic for: Symbyax - Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg
Approved: June 22, 2012 - Actavis Elizabeth LLC
Generic for: Adderall XR - Metformin Hydrochloride and Pioglitazone Hydrochloride Tablets 500 mg/15 mg (base) and 850 mg/15 mg (base)
Approved: June 26, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Actoplus Met - Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/5%
Approved: June 26, 2012 - Perrigo Israel Pharmaceuticals Ltd.
Generic for: Duac Topical Gel - Linezolid Injection 200 mg/100 mL
Approved: June 27, 2012 - Teva Pharmaceuticals USA Inc.
Generic for: Zyvox Injection - Cidofovir Injection 75 mg (base)/mL
Approved: June 27, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Vistide
July
- Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
Approved: July 3, 2012 - Lupin Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.
Generic for: Lyrica - Diclofenac Sodium and Misoprostol Delayed Release Tablets 50 mg/0.2 mg and 75 mg/0.2 mg
Approved: July 9, 2012 - Watson Pharmaceuticals, Inc.
Generic for: Arthrotec - Levonorgestrel Tablets (Next Choice One Dose) 1.5 mg
Approved: July 12, 2012 - Watson Pharmaceuticals, Inc.
Generic for: Plan B One-Step - Phenoxybenzamine Hydrochloride Capsules USP, 10 mg
Approved: July 16, 2012 - Roxane Laboratories, Inc.
Generic for: Dibenzyline - Modafinil Tablets 100 mg and 200 mg
Approved: July 16, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Provigil - Entacapone Tablets 200 mg
Approved: July 16, 2012 - Sun Pharma Global
Generic for: Comtan - Methylphenidate Hydrochloride Extended-Release Capsules (CD) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg
Approved: July 19, 2012 - Teva Pharmaceuticals USA
Generic for: Metadate CD - Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL
Approved: July 25, 2012 - Actavis Mid Atlantic
Generic for: Allegra Oral Suspension
August
- Montelukast Sodium Tablets 10 mg (base)
Approved: August 3, 2012 - Apotex Inc.; Aurobindo Pharma; Endo Pharmaceuticals; Glenmark Generics; Kudco Ireland Inc.; Mylan Inc.; Roxane Laboratories; Sandoz Inc.; Teva Pharmaceuticals Inc.; Torrent Pharmaceuticals
Generic for: Singulair Tablets - Montelukast Sodium Chewable Tablets 4 mg (base) and 5 mg (base)
Approved: August 3, 2012 - Apotex Inc.; Aurobindo Pharma; Endo Pharmaceuticals; Kudco Ireland Inc.; Mylan Inc.; Roxane Laboratories; Sandoz Inc.; Teva Pharmaceuticals Inc.; Torrent Pharmaceuticals
Generic for: Singulair Chewable Tablets - Montelukast Sodium Granules 4 mg (base)/packet
Approved: August 3, 2012 - Teva Pharmaceuticals Inc.
Generic for: Singulair Granules - Didanosine Chewable Tablets 100 mg, 150 mg and 200 mg
Approved: August 14, 2012 - Aurobindo Pharma Limited
Generic for: Videx Chewable Tablets - Clobetasol Propionate Foam 0.05%
Approved: August 14, 2012 - Perrigo Israel Pharmaceuticals, Ltd.
Generic for: Olux E Foam - Pioglitazone Hydrochloride Tablets 15 mg (base), 30 mg (base) and 45 mg (base)
Approved: August 17, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Actos - Mycophenolic Acid Delayed-Release Tablets 180 mg
Approved: August 21, 2012 - Apotex Corp.
Generic for: Myfortic - Nedocromil Sodium Ophthalmic Solution 2%
Approved: August 22, 2012 - Akorn, Inc.
Generic for: Alocril - Lidocaine Topical Patch 5%
Approved: August 23, 2012 - Watson Pharmaceuticals, Inc.
Generic for: Lidoderm - Armodafinil Tablets 100 mg and 200 mg
Approved: August 29, 2012 - Watson Laboratories, Inc.
Generic for: Nuvigil - Azelastine Hydrochloride Nasal Solution, (Nasal Spray) 0.15% (0.187 mg (base)/spray)
Approved: August 31, 2012 - Apotex Inc.
Generic for: Astepro
September
- Valsartan and Hydrochlorothiazide Tablets USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg
Approved: September 21, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Diovan HCT - Aprepitant Capsules 40 mg, 80 mg and 125 mg
Approved: September 24, 2012 - Sandoz Inc.
Generic for: Emend - Tolterodine Tartrate Tablets 1 mg and 2 mg
Approved: September 25, 2012 - Apotex Corp.
Generic for: Detrol - Amlodipine Besylate, Hydrochlorothiazide and Valsartan Tablets 5 mg/12.5 mg/160 mg, 10 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg
Approved: September 25, 2012 - Teva Pharmaceuticals USA Inc.
Generic for: Exforge HCT - Quinine Sulfate Capsules USP, 324 mg
Approved: September 28, 2012 - Teva Pharmaceuticals, USA
Generic for: Qualaquin - Progesterone Capsules 100 mg and 200 mg
Approved: September 28, 2012 - Sofgen Pharmaceuticals, LLC
Generic for: Prometrium
October
- Guanfacine Hydrochloride Extended Release Tablets 1mg (base), 2 mg (base), 3 mg (base) and 4 mg (base)
Approved: October 5, 2012 - Actavis Elizabeth LLC
Generic for: Intuniv - Trospium Chloride Extended Release Capsules 60 mg
Approved: October 12, 2012 - Watson Laboratories, Inc.
Generic for: Sanctura XR - Griseofulvin Ultramicrosize Tablets USP, 125 mg and 250 mg
Approved: October 22, 2012 - Sigmapharm Laboratories, LLC
Generic for: Gris-PEG
November
- Sildenafil Citrate Tablets 20 mg (base)
Approved: November 6, 2012 - Apotex Corp.; Torrent Pharmaceuticals Limited; Watson Laboratories, Inc.; Dr. Reddy's Laboratories Limited
Generic for: Revatio - Betamethasone Valerate Aerosol Foam 0.12% (base)
Approved: November 26, 2012 - Cobrek Pharmaceuticals, Inc.
Generic for: Luxiq
December
- Candesartan Cilexetil and Hydrochlorothiazide Tablets 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25 mg (Mylan only)
Approved: December 4, 2012 - Apotex Corp.; Mylan Pharmaceuticals Inc.
Generic for: Atacand HCT - Phenytoin Chewable Tablets USP, 50 mg
Approved: December 26, 2012 - Mylan Pharmaceuticals, Inc.
Generic for: Dilantin Chewable Tablets - Lamotrigine Extended-Release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg and 300 mg
Approved: December 26, 2012 - Anchen Pharmaceuticals, Inc.
Generic for: Lamictal XR - Tranexamic Acid Tablets 650 mg
Approved: December 27, 2012 - Watson Laboratories, Inc.
Generic for: Lysteda - Methylphenidate Hydrochloride Extended Release Tablets 27 mg, 36 mg and 54 mg
Approved: December 28, 2012 - Mallinckrodt, Inc.
Generic for: Concerta - Rizatriptan Benzoate Tablets 5 mg (base) and 10 mg (base)
Approved: December 31, 2012 - Apotex Corp.; Aurobindo Pharma Limited; Glenmark Generics Inc., USA; Mylan Pharmaceuticals Inc.; Natco Pharma Limited; Sandoz Inc.; Sun Pharma Global Inc.; Teva Pharmaceuticals USA;
Generic for: Maxalt - Rizatriptan Benzoate Orally Disintegrating Tablets 5 mg (base) and 10 mg (base)
Approved: December 31, 2012 - Mylan Pharmaceuticals Inc.
Generic for: Maxalt-MLT