First-Time Generic Drug Approvals for 2009
January
- Galantamine Hydrobromide Oral Solution 4 mg/mL
Approved: January 30, 2009 Roxane Laboratories, Inc.
Generic for: Razadyne Oral Solution - Risperidone Oral Solution 1 mg/mL
Approved: January 30, 2009 Teva Pharmaceuticals USA
Generic for: Risperdal Oral Solution - Divalproex Sodium Extended-Release Tablets 250 mg and 500 mg
Approved: January 29, 2009 Mylan Pharmaceuticals, Inc.
Generic for: Depakote ER Tablets, 250 mg and 500 mg - Divalproex Sodium Delayed Release Capsules (Sprinkle) 125 mg (valproic acid equivalent)
Approved: January 23, 2009 Dr. Reddy's Laboratories, Inc.
Generic for: Depakote Sprinkle Capsules, 125 mg - Levetiracetam Oral Solution 100 mg/mL
Approved: January 15, 2009 Roxane Laboratories, Inc.; Tolmar Inc.; Aurobindo Pharma Ltd.; Actavis Mid Atlantic LLC
Generic for: Keppra Oral Solution - Alprazolam Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg
Approved: January 9, 2009 Kali Laboratories, Inc.
Generic for: Niravam Orally Disintegrating Tablets
February
- Risperidone Orally Disintegrating Tablets 0.5 mg and 2 mg
Approved: February 24, 2009 Dr. Reddy's Laboratories Limited
Generic for: Risperdal M-Tab (Orally Disintegrating Tablet) - Sumatriptan Succinate Tablets 25 mg (base), 50 mg (base) and 100 mg (base)
Approved: February 9, 2009 Teva Pharmaceuticals USA; Ranbaxy Laboratories Limited (100 mg (base) only)
Generic for: Imitrex Tablets - Sumatriptan Succinate Injection (Syringe) 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL; Pre-Filled Syringes
Approved: February 6, 2009 Teva Parenteral Medicines
Generic for: Imitrex Injection, Pre-Filled Syringes - Sumatriptan Succinate Injection 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL; Single-Dose Vials
Approved: February 6, 2009 Sandoz Canada, Inc.; Teva Parenteral Medicines (6 mg (base)/0.5 mL only); Bedford Laboratories (6 mg (base)/0.5 mL only)
Generic for: Imitrex Injection, Single Dose Vials - Minocycline Hydrochloride Extended-Release Tablets 45 mg (base), 90 mg (base) and 135 mg (base)
Approved: February 3, 2009 Impax Laboratories, Inc.
Generic for: Solodyn Tablets
March
- Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg
Approved: March 31, 2009 Taro Pharmaceuticals USA, Inc.
Generic for: Tegretol-XR Tablets - Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.02 mg (28-Day Regimen)
Approved: March 30, 2009 Barr Laboratories, Inc.
Generic for: Yaz Tablets - Topiramate Tablets 25 mg, 50 mg, 100 mg and 200 mg
Approved: March 27, 2009 Torrent Pharmaceuticals Limited; Ranbaxy Laboratories Limited (not 50 mg); Par Pharmaceutical, Inc.; Cipla Limited; Mylan Pharmaceuticals Inc.; Apotex Inc.; Cobalt Laboratories; Glenmark Generics Limited; Roxane Laboratories, Inc.; Barr Laboratories, Inc. (not 50 mg); Sun Pharmaceutical Industries, Ltd.; Invagen Pharmaceuticals, Inc.; Aurobindo Pharma Limited; Unichem Laboratories Limited (not 200 mg); Zydus Pharmaceuticals USA, Inc.; Teva Pharmaceuticals USA
Generic for: Topamax Tablets - Ibuprofen Capsules, 200 mg (Liquid Filled Capsule) (OTC)
Approved: March 24, 2009 Banner Pharmacaps, Inc.
Generic for: Advil Liqui-Gels Capsules - Levalbuterol Inhalation Solution USP, (Concentrate) 0.25% (1.25 mg/0.5mL)
Approved: March 20, 2009 Dey LP
Generic for: Xopenex Inhalation Solution (Concentrate) - Liothyronine Sodium Tablets USP 5 mcg, 25 mcg, and 50 mcg
Approved: March 20, 2009 Coastal Pharmaceuticals
Generic for: Cytomel Tablets - Apraclonidine Ophthalmic Solution USP 0.5% (base)
Approved: March 12, 2009 Akorn, Inc.
Generic for: Iopidine Ophthalmic Solution, 0.5% - Malathion Lotion USP 0.5%
Approved: March 6, 2009 Synerx Pharma, LLC
Generic for: Ovide Lotion, 0.5%
April
- Risperidone Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg
Approved: April 30, 2009 Kali Laboratories, Inc.
Generic for: Risperdal-M Tab (Orally Disintegrating Tablet) - Mivacurium Chloride Injection 2 mg (base)/mL; packaged in 10 mg (base)/5 mL and 20 mg (base)/10 mL single-dose vials
Approved: April 30, 2009 Ebewe Parenta Pharmaceuticals, Inc.
Generic for: Mivacron Injection - Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1% [125 mcg (base)/spray]
Approved: April 30, 2009 Apotex Inc.
Generic for: Astelin Nasal Spray - Lorazepam Oral Concentrate USP 2 mg/mL
Approved: April 28, 2009 Paddock Laboratories, Inc.
Generic for: Lorazepam Intensol - Topiramate Capsules (Sprinkle) 15 mg and 25 mg
Approved: April 15, 2009 Cobalt Laboratories, Inc.; Barr Laboratories, Inc.
Generic for: Topamax Sprinkle Capsules
May
- Triamcinolone Acetonide Injectable Suspension USP 10 mg/mL; packaged in 50 mg/5 mL multiple-dose vials
Approved: May 27, 2009 Sandoz Canada, Inc.
Generic for: Kenalog-10 Injectable Suspension
June
- Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg; 0.215 mg/0.025 mg and 0.250 mg/0.025 mg (28-Day Regimen)
Approved: June 29, 2009 Barr Laboratories, Inc.
Generic for: Ortho Tri Cyclen Lo - Oxcarbazepine Oral Suspension 300 mg/5 mL
Approved: June 26, 2009 Ranbaxy Laboratories Limited
Generic for: Trileptal Oral Suspension - Levonorgestrel Tablets (Rx) 0.75 mg
Approved: June 24, 2009 Watson Laboratories, Inc.
Generic for: Plan B (levonorgestrel) Tablets, 0.75 mg - Melphalan Hydrochloride for Injection 50 mg (base)/vial
Approved: June 9, 2009 Synerx Pharma, LLC
Generic for: Alkeran for Injection - Omeprazole Magnesium Delayed-Release Capsules (OTC) 20 mg (base)
Approved: June 6, 2009 Dr. Reddy's Laboratories Limited
Generic for: Prilosec OTC Delayed-Release Capsules - Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL; packaged in 40 mg/1 mL vials and 200 mg/5 mL and 400 mg/10 mL multiple-dose vials
Approved: June 1, 2009 Sandoz Canada Inc.
Generic for: Kenalog-40 Injectable Suspension
July
- Bicalutamide Tablets 50 mg
Approved: July 6, 2009 Teva Pharmaceuticals; Synthon Pharmaceuticals, Inc.; Kudco; Sandoz; Accord Healthcare Inc.; Zydus Pharmaceuticals; Sun Pharmaceutical Industries Ltd; Mylan Pharmaceuticals
Generic for: Casodex
August
- Azelastine Hydrochloride Ophthalmic Solution 0.05%
Approved: August 3, 2009 Apotex Inc.
Generic for: Optivar Ophthalmic Solution - Oxaliplatin Injection 5 mg/mL; (preservative-free), packaged in 50 mg/10 mL and 100 mg/20 mL single-use vials
Approved: August 7, 2009 Hospira Worldwide; Sun Pharma Global; Fresenius Kabi Oncology
Generic for: Eloxatin Injection - Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg
Approved: August 10, 2009 Sandoz, Inc.
Generic for: Prograf Capsules - Clindamycin Phosphate and Benzoyl Peroxide Gel 1% (base)/5%
Approved: August 11, 2009 Dow Pharmaceutical Sciences, Inc.
Generic for: Benzaclin Topical Gel - Aspirin and Dipyridamole Extended-Release Capsules 25 mg/200 mg
Approved: August 14, 2009 Barr Laboratories, Inc.
Generic for: Aggrenox Extended-Release Capsules - Clonidine Transdermal System USP 0.1 mg/day, 0.2 mg/day and 0.3 mg/day
Approved: August 18, 2009 Aveva Drug Delivery Systems, Inc.
Generic for: Catapres-TTS - Levonorgestrel Tablets (Rx/OTC) 0.75 mg
Approved: August 28, 2009 Watson Laboratories, Inc.
Generic for: Plan B Tablets
September
- Norethindrone Acetate & Ethinyl Estradiol Tablets USP, & Fe 1 mg/0.02 mg with 75 mg Ferrous Fumarate (24-Day Regimen)
Approved: September 1, 2009 Watson Laboratotries, Inc.
Generic for: Loestrin 24 Fe Tablets - Temazepam Capsules USP, 7.5 mg
Approved: September 8, 2009 Mutual Pharmaceutical Company, Inc.
Generic for: Restoril Capsules 7.5 mg - Nateglinide Tablets 60 mg and 120 mg
Approved: September 9, 2009 Par Pharmaceutical, Inc.; Dr. Reddy's Laboratories; Teva Pharmaceuticals USA
Generic for: Starlix Tablets - Piperacillin and Tazobactam for Injection 36 g (base)/4.5 g (base)/vial, (pharmacy bulk package)
Approved: September 15, 2009 Orchid Healthcare
Generic for: Zosyn for Injection (Pharmacy Bulk Package) - Piperacillin and Tazobactam for Injection 2 g (base)/250 mg (base)/vial, 3 g (base)/375 mg (base)/vial and 4 g (base)/500 mg (base)/vial
Approved: September 15, 2009 Orchid Healthcare
Generic for: Zosyn for Injection
October
- Buprenorphine Hydrochloride Sublingual Tablets 2 mg (base) and 8 mg (base)
Approved: October 8, 2009 Roxane Laboratories, Inc.
Generic for: Subutex - Chlorothiazide Sodium for Injection, USP 500 mg (base)/vial
Approved: October 16, 2009 APP Pharmaceuticals, Inc.
Generic for: Diuril for Injection
November
- Ketorolac Tromethamine Ophthalmic Solution 0.5%
Approved: November 5, 2009 Alcon Inc.; Akorn Inc.; Sun Pharma Global, Inc.
Generic for: Acular Ophthalmic Solution - Ketorolac Tromethamine Ophthalmic Solution 0.4%
Approved: November 5, 2009 Apotex Inc.; Alcon Inc.; Akorn Inc.
Generic for: Acular LS Ophthalmic Solution - Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.005 mg
Approved: November 6, 2009 Barr Laboratories, Inc.
Generic for: Femhrt Tablets 1 mg/0.005 mg - Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg
Approved: November 10, 2009 Teva Pharmaceuticals USA; Matrix Laboratories Limited
Generic for: Prevacid Delayed-Release Capsules - Perindopril Erbumine Tablets 2 mg, 4 mg and 8 mg
Approved: November 10, 2009 Aurobindo Pharma Limited; Roxane Laboratories, Inc.; IVAX Pharmaceuticals, Inc.
Generic for: Aceon Tablets - Tramadol Hydrochloride Extended-Release Tablets 100 mg and 200 mg
Approved: November 13, 2009 Par Pharmaceutical, Inc.
Generic for: Ultram ER Tablets, 100 mg and 200 mg - Nicardipine Hydrochloride Injection 2.5 mg/mL; packaged in 25 mg/10 mL Single-Dise Vials
Approved: November 17, 2009 Generamedix, Inc.; Pharmaforce, Inc.; Navinta, LLC; Sun Pharma Global, Inc.; Wockhardt Limited
Generic for: Cardene I.V. Injection - Nizatidine Oral Solution 15 mg/mL
Approved: November 18, 2009 Amneal Pharmaceuticals
Generic for: Axid Oral Solution
December
- Donepezil Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg
Approved: December 11, 2009 URL Pharma, Inc.
Generic for: Aricept ODT - Cromolyn Sodium Oral Concentrate 100 mg/ 5 mL
Approved: December 18, 2009 Genera Pharmaceuticals, LLC
Generic for: Gastrocrom - Cosyntropin Injection 0.25 mg/vial
Approved: December 23, 2009 GeneraMedix Inc.
Generic for: Cortrosyn