First-Time Generic Drug Approvals for 2011
January
- Fentanyl Citrate Buccal Tablets, USP 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg and 0.8 mg
Approved: January 7, 2011 - Watson Pharmaceuticals, Inc.
Generic for: Fentora - Atovaquone and Proguanil Hydrochloride Tablets 250 mg/100 mg
Approved: January 12, 2011 - Glenmark Generics Inc.
Generic for: Malarone - Gabapentin Oral Solution 250 mg/5 mL
Approved: February 18, 2011 - Hi-Tech Pharmacal Co., Inc.
Generic for: Neurontin Oral Solution - Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/500 mg and 15 mg/850 mg
Approved: February 25, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Actoplus Met Tablets - Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg (28-Day Regimen)
Approved: March 9, 2011 - Watson Laboratories, Inc.
Generic for: Ortho Tri-Cyclen Lo Tablets - Epinastine Hydrochloride Ophthalmic Solution 0.05%
Approved: March 14, 2011 - Cypress Pharmaceutical, Inc.
Generic for: Elestat Ophthalmic Solution - Exemestane Tablets 25 mg
Approved: April 1, 2011 - Roxane Laboratories, Inc.
Generic for: Aromasin Tablets - Paroxetine Hydrochloride Extended-Release Tablets 37.5 mg (base)
Approved: April 14, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Paxil CR Tablets - Cyclobenzaprine Hydrochloride Extended-Release Capsules 15 mg and 30 mg
Approved: April 18, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Amrix Extended-Release Capsules - Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets 5 mg/240 mg (24-Hour Formulation)
Approved: April 26, 2011 - Dr. Reddy's Laboratories Limited
Generic for: Clarinex-D 24-Hour Extended-Release Tablets - Fluticasone Propionate Topical Lotion 0.05%
Approved: May 2, 2011 - Glenmark Generics Inc.
Generic for: Cutivate Lotion - Methylergonovine Maleate Tablets 0.2 mg
Approved: May 2, 2011 - Novel Laboratories, Inc.
Generic for: Methergine Tablets - Bromfenac Sodium Ophthalmic Solution/Drops 0.09%
Approved: May 11, 2011 - Coastal Pharmaceuticals
Generic for: Xibrom - Nitrofurantoin Oral Suspension 25 mg/5 mL
Approved: May 11, 2011 - Amneal Pharmaceuticals
Generic for: Furadantin Suspension - Budesonide Capsules 3 mg
Approved: May 16, 2011 - Mylan Pharmaceuticals Inc.
Generic for: Entocort EC - Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg
Approved: May 20, 2011 - Nostrum Pharmaceuticals, LLC
Generic for: Carbatrol Capsules - Eszopiclone Tablets 1 mg, 2 mg and 3 mg
Approved: May 23, 2011 - Teva Pharmaceuticals USA
Generic for: Lunesta - Lamivudine and Zidovudine Tablets 150 mg/300 mg
Approved: May 25, 2011 - Teva Pharmaceuticals USA Inc.
Generic for: Combivir - Ethinyl Estradiol/Levonorgestrel and Ethinyl Estradiol Tablets 0.03 mg/0.15 mg and 0.01 mg
Approved: May 31, 2011 - Watson Laboratories, Inc.
Generic for: Seasonique - Ethinyl Estradiol and Levonorgestrel Tablets USP 0.02 mg/0.09 mg
Approved: June 6, 2011 - Watson Laboratories, Inc.
Generic for: Lybrel - Clobetasol Propionate Shampoo 0.05%
Approved: June 7, 2011 - Actavis Mid Atlantic, LLC
Generic for: Clobex Shampoo - Clobetasol Propionate Topical Solution USP, (Spray) 0.05%
Approved: June 16, 2011 - Paddock Laboratories, Inc.
Generic for: Clobex Spray - Levofloxacin Injection 25 mg/mL; packaged in 500 mg/20 mL and 750 mg/30 mL Single-Use Vials
Approved: June 20, 2011 - Akorn, Inc.; Sagent Strides, LLC
Generic for: Levaquin Injection - Levofloxacin Tablets 250 mg, 500 mg and 750 mg
Approved: June 20, 2011 - Aurobindo Pharma Limited; Sandoz, Inc.; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Dr. Reddy's Laboratories Limited; Torrent Pharmaceuticals; Wockhardt Limited; Glenmark Generics Ltd.
Generic for: Levaquin Tablets - Levofloxacin Oral Solution 25 mg/mL
Approved: June 20, 2011 - Hi-Tech Pharmacal Co., Inc.
Generic for: Levaquin Oral Solution - Sumatriptan Succinate Injection 6 mg (base)/0.5 mL; packaged in a Single-Dose Syringe With Autoinjector
Approved: June 21, 2011 - Sun Pharma Global FZE
Generic for: Imitrex Statdose System - Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets USP, (OTC) 180 mg/240 mg (24-Hour Formulation)
Approved: June 22, 2011 - Dr. Reddy's Laboratories Limited
Generic for: Allegra-D 24 Hour Extended-Release Tablets - Flucytosine Capsules USP, 250 mg and 500 mg
Approved: June 28, 2011 - Sigmapharm Laboratories, LLC
Generic for: Ancobon -
Fondaparinux Sodium Injection 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL
Approved: July 11, 2011 - Dr. Reddy's Laboratories Limited
Generic for: Arixtra -
Alfuzosin Hydrochloride Extended-Release Tablets 10 mg
Approved: July 18, 2011 - Apotex Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals; Teva Pharmaceuticals USA; Sun Pharmaceutical Industries Limited
Generic for: Uroxatral -
Metronidazole Topical Gel 1%
Approved: July 22, 2011 - Tolmar, Inc.
Generic for: Metrogel 1% - Paricalcitol Injection USP, 2 mcg/mL and 5 mcg/mL
Approved: July 27, 2011 - Sandoz Canada, Inc.
Generic for: Zemplar Injection -
Phentermine Resin Complex Extended-Release Capsules 15 mg (base) and 30 mg (base)
Approved: July 28, 2011 - Lannett Company, Inc.
Generic for: Ionamin -
Tranexamic Acid Injection 100 mg/mL; packaged in 1000 mg/10 mL single-dose vials
Approved: August 10, 2011 - Pharmaforce Inc.
Generic for: Cyklokapron Injection -
Gatifloxacin Ophthalmic Solution 0.3%
Approved: August 19, 2011 - Apotex Corp.
Generic for: Zymar Ophthalmic Solution -
Ketoconazole Foam 2%
Approved: August 25, 2011 - Perrigo Israel Pharmaceuticals Ltd.
Generic for: Extina Foam, 2% -
Cevimeline Hydrochloride Capsules 30 mg
Approved: August 25, 2011 - Apotex Inc.
Generic for: Evoxac Capsules, 30 mg -
Prilocaine Hydrochloride with Epinephrine Injection USP, 4%/1:200,000; packaged in cartridges for dental use
Approved: August 30, 2011 - Septodont Inc.
Generic for: Citanest Forte Dental -
Levetiracetam Extended-Release Tablets 500 mg and 750 mg
Approved: September 12, 2011 - Actavis Elizabeth LLC; Par Pharmaceutical, Inc.; Apotex, Watson Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Teva Pharmaceuticals USA
Generic for: Keppra XR -
Felbamate Tablets 400 mg and 600 mg
Approved: September 13, 2011 - Amneal Pharmaceuticals
Generic for: Felbatol Tablets -
Doxercalciferol Capsules 0.5 mcg
Approved: September 23, 2011 - Roxane Laboratories, Inc.
Generic for: Hectorol Capsules - Fluocinolone Acetonide Otic Oil 0.01%
Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
Generic for: DermOtic Oil - Fluocinolone Acetonide Topical Oil 0.01%
Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
Generic for: Derma-Smoothe/FS Scalp Oil - Fluocinolone Acetonide Topical Oil 0.01%
Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
Generic for: Derma-Smoothe/FS Body Oil - Olanzapine Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg
Approved: October 24, 2011 - Teva Pharmaceuticals USA
Generic for: Zyprexa - Olanzapine Tablets 20 mg
Approved: October 24, 2011 - Dr. Reddy's Laboratories Ltd.
Generic for: Zyprexa
Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg and 20 mg - Olanzapine Intramuscular Injection 10 mg/vial
Approved: October 24, 2011 - InnoPharma LLC
Generic for: Zyprexa Injection - Diethylpropion Hydrochloride Extended-Release Tablets 75 mg
Approved: October 24, 2011 - Lannett Company, Inc.
Generic for: Tenuate Dospan - Memantine Hydrochloride Tablets 5 mg and 10 mg
Approved: October 25, 2011 - Teva Pharmaceuticals USA
Generic for: Namenda - Levonorgestrel & Ethinyl Estradiol Tablets and Ethinyl Estradiol 0.1 mg/0.02 mg; 0.01 mg
Approved: October 25, 2011 - Watson Laboratories, Inc.
Generic for: Lo Seasonique - Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL
Approved: October 27, 2011 - Pack Pharmaceuticals LLC
Generic for: Gastrocrom Oral Concentrate - Epinastine Hydrochloride Ophthalmic Solution 0.05%
Approved: October 31, 2011 - Pharmaforce Inc.
Generic for: Elestat - Tiagabine Hydrochloride Tablets 2 mg and 4 mg
Approved: November 4, 2011 - Sun Pharmaceutical Industries, Ltd.
Generic for: Gabitril - Levocetirizine Dihydrochloride Oral Solution 2.5 mg/5 mL
Approved: November 7, 2011 - Synthon Pharmaceuticals, Inc.
Generic for: Xyzal Oral Solution - Morphine Sulfate Extended-Release Capsules USP 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg
Approved: November 10, 2011 - Watson Laboratories, Inc.
Generic for: Kadian - Eprosartan Mesylate Tablets 400 mg (base) and 600 mg (base)
Approved: November 16, 2011 - Mylan Pharmaceuticals, Inc.
Generic for: Teveten - Imipenem and Cilastatin for Injection USP, (I.V.) 250 mg/250 mg (base) and 500 mg/500 mg (base)
Approved: November 16, 2011 - Hospira Inc.
Generic for: Primaxin I.V. - Lamivudine Tablets 150 mg and 300 mg
Approved: November 17, 2011 - Aurobindo Pharma USA, Inc.
Generic for: Epivir Tablets - Sodium Phenylbutyrate Tablets 500 mg
Approved: November 18, 2011 - Amplogen Pharmaceuticals, LLC
Generic for: Buphenyl Tablets - Atorvastatin Calcium Tablets 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base)
Approved: November 30, 2011 - Ranbaxy Laboratories Limited
Generic for: Lipitor - Methylphenidate Hydrochloride Extended-Release Capsules (LA) 20 mg, 30 mg and 40 mg
Approved: December 1, 2011 - Actavis South Atlantic LLC
Generic for: Ritalin LA Capsules - Felbamate Oral Suspension 600 mg/5 mL
Approved: December 16, 2011 - Amneal Pharmaceuticals
Generic for: Felbatol Oral Suspension - Fenofibrate Tablets 48 mg and 145 mg
Approved: December 23, 2011 - Lupin Limited
Generic for: Tricor Tablets - Tramadol Hydrochloride Extended-Release Tablets 100 mg, 200 mg and 300 mg (Once Daily)
Approved: December 30, 2011 - Sun Pharma Global FZE
Generic for: Ryzolt Tablets
February
March
April
May
June
July
August
September
October
Approved: October 24, 2011 - Dr. Reddy's Laboratories Ltd.; Par Pharmaceutical; Apotex Corp.
Generic for: Zyprexa Zydus