First-Time Generic Drug Approvals for 2010
January
- Ibutilide Fumarate Injection 0.1 mg/mL
Approved: January 11, 2010 PharmaForce, Inc.; Bioniche Pharma USA LLC.; GeneraMedix Inc.
Generic for: Corvert
February
- Desloratadine Tablets 5 mg
Approved: February 19, 2010 Company: Orchid Healthcare
Generic for: Clarinex Tablets - Imiquimod Cream 5%
Approved: February 25, 2010 Company: Nycomed US, Inc.
Generic for: Aldara Cream
March
- Temozolomide Capsules 5 mg, 20 mg, 100 mg, 250 mg, 140 mg and 180 mg
Approved: March 1, 2010 Barr Pharmaceuticals, Inc.
Generic for: Temodar - Tamsulosin Hydrochloride Capsules 0.4 mg
Approved: March 2, 2010 Impax Laboratories, Inc.
Generic for: Flomax - Dactinomycin Injection 0.5 mg/vial
Approved: March 16, 2010 Bedford Laboratories
Generic for: Cosmegen - Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets 180 mg / 240 mg
Approved: March 17, 2010 Company: Dr. Reddy's Laboratories Limited
Generic for: Allegra-D 24 Hour - Metaxalone Tablets 800 mg
Approved: March 31, 2010 Company: Sandoz Inc.
Generic for: Skelaxin
April
- Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg and 100 mg/25 mg
Approved: April 6, 2010 Teva Pharmaceuticals USA
Generic for: Hyzaar Tablets - Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg
Approved: April 6, 2010 Roxane Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Ltd.; Teva Pharmaceuticals USA
Generic for: Hyzaar Tablets - Losartan Potassium Tablets USP, 25 mg, 50 mg and 100 mg
Approved: April 6, 2010 Teva Pharmaceuticals USA
Generic for: Cozaar Tablets - Memantine Hydrochloride Tablets 5 mg and 10 mg
Approved: April 14, 2010 Dr. Reddy's Laboratories Limited
Generic for: Namenda Tablets - Imipramine Pamoate Capsules 75 mg, 100 mg, 125 mg and 150 mg
Approved: April 14, 2010 Roxane Laboratories, Inc.; Lupin Limited
Generic for: Tofranil-PM Capsules - Amoxicillin & Clavulanate Potassium Extended-Release Tablets 1000 mg/62.5 mg (base)
Approved: April 21, 2010 Sandoz Inc.
Generic for: Augmentin XR Tablets - Voriconazole Tablets 50 mg and 200 mg
Approved: April 22, 2010 Matrix Laboratories Limited
Generic for: Vfend Tablets
May
- Metronidazole Extended-Release Tablets 750 mg
Approved: May 5, 2010 - Alembic Limited
Generic for: Flagyl ER Tablets, 750 mg - Trandolapril and Verapamil Hydrochloride Extended Release Tablets 2 mg/180 mg, 2 mg/240 mg and 4 mg/240 mg
Approved: May 5 and 26, 2010 - Glenmark Generics Ltd.
Generic for: Tarka - Zidovudine Injection 10 mg/mL
Approved: May 6, 2010 - PharmaForce, Inc.
Generic for: Retrovir Injection - Omeprazole and Sodium Bicarbonate Capsules 20 mg/1.1 g and 40 mg/1.1 g
Approved: May 25, 2010 - Par Pharmaceutical
Generic for: Zegerid - Levetiracetam Injection 100 mg/mL; packaged in 500 mg/5 mL Single-Use Vials
Approved May 26, 2010 - Nexus Pharmaceuticals, Inc.
Generic for: Keppra Injection - Famotidine for Suspension 40 mg/5 mL
Approved: May 27, 2010 - Navinta LLC
Generic for: Pepcid for Suspension
June
- Chlorzoxazone Tablets USP, 375 mg and 750 mg
Approved: June 1, 2010 - Mikart Inc.
Generic for: Parafon Forte DSC Caplets - Adapalene Gel 0.1%
Approved: June 2, 2010 - Pliva Hrvatska D.O.O.
Generic for: Differin Gel - Miconazole Nitrate Vaginal Insert & Miconazole Nitrate Cream 1200 mg/2%
Approved: June 2, 2010 - Perrigo R&D Company
Generic for: Monistat 1 Combination Pack - Oxymorphone Hydrochloride Extended-Release Tablets 5 mg, 10 mg, 20 mg and 40 mg
Approved: June 14, 2010 - Impax Laboratories, Inc.
Generic for: Opana ER Tablets - Aztreonam for Injection USP, 500 mg/vial, 1 g/vial and 2 g/vial
Approved: June 18, 2010 - APP Pharmaceuticals, LLC
Generic for: Azactam for Injection - Articaine Hydrochloride and Epinephrine Injection 4%/1:100,000 (Dental Cartridge)
Approved: June 18, 2010 - Hospira Inc.
Generic for: Septocaine and Epinephrine Injection (4%/1:100,000) - Meropenem for Injection USP, 500 mg/vial and 1 g/vial
Approved: June 22, 2010 - Hospira, Inc.
Generic for: Merrem I.V. for Injection - Anastrozole Tablets 1 mg
Approved: June 28, 2010 - Accord Healthcare Inc., USA; Natco Pharma Limited; Sandoz Inc.;Stason Pharmaceuticals, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Three Rivers Pharmaceuticals, LLC; Fresenius Kabi Oncology plc;Synthon Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Watson Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.
Generic for: Arimidex Tablets - Venlafaxine Hydrochloride Extended-Release Capsules 37.5 mg (base), 75 mg (base) and 150 mg (base)
Approved: June 28, 2010 - Teva Pharmaceuticals USA
Generic for: Effexor XR Capsules - Adapalene Cream 0.1%
Approved: June 30, 2010 - Nycomed US, Inc.
Generic for: Differin Cream
July
- Naratriptan Hydrochloride Tablets 1 mg (base) and 2.5 mg (base)
Approved: July 7, 2010 - Teva Pharmaceuticals USA Inc.; Sandoz Inc.; Roxane Laboratories, Inc.
Generic for: Amerge - Clindamycin Palmitate Hydrochloride for Oral Solution 75 mg (base)/5 mL
Approved: July 7, 2010 - Paddock Laboratories, Inc.
Generic for: Cleocin Pediatric Flavored Granules For Oral Solution - Desloratadine Orally Disintegrating Tablets 2.5 mg and 5 mg
Approved: July 12, 2010 - Dr.Reddy's Pharmaceutical Company
Generic for: Clarinex Reditabs
August
- Norethindrone and Ethinyl Estradiol Tablets (Chewable), and Ferrous Fumarate Tablets, (Chewable) 0.4 mg/0.035 mg/75 mg (28-Day Regimen)
Approved: August 5, 2010 - Barr Laboratories, Inc.
Generic for: Femcon Fe - Trospium Chloride Tablets 20 mg
Approved: August 13, 2010 - Glenmark Generics Ltd.
Generic for: Sanctura - Atomoxetine Hydrochloride Capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
Approved: August 30, 2010 - Actavis Elizabeth LLC; Sun Pharma Global; Mylan Pharmaceuticals, Inc.
Generic for: Strattera
September
- Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.03 mg
Approved September 7, 2010 Watson Laboratories, Inc.
Generic for: Yasmin Tablets - Oxymorphone Hydrochloride Tablets 5 mg and 10 mg
Approved: September 27, 2010 - Roxane Laboratories, Inc.
Generic for: Opana - Naphazoline HCl and Pheniramine Maleate Ophthalmic Solution USP 0.027%/0.315% (OTC)
Approved: September 27, 2010 Altaire Pharmaceuticals, Inc.
Generic for: Opcon-A
October
- Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL
Approved: October 1, 2010 - Tris Pharma, Inc.
Generic for: Tussionex Pennkinetic Extended-Release Oral Suspension - Zolpidem Tartrate Extended-Release Tablets USP 6.25 mg
Approved: October 13, 2010 - Actavis South Atlantic LLC
Generic for: Ambien CR - Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg and 30 mg
Approved: October 15, 2010 - Teva Pharmaceuticals USA
Generic for: Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets - Propafenone Hydrochloride Extended-Release Capsules 225 mg, 325 mg and 425 mg
Approved: October 18, 2010 - Par Pharmaceutical, Inc.
Generic for: Rythmol SR Capsules
November
- Gemcitabine Hydrochloride Injection 2 g base/vial
Approved: November 15, 2010 - Hospira Inc.
Generic for: Gemzar - Zafirlukast Tablets 10 mg and 20 mg
Approved: November 18, 2010 - Dr Reddys Laboratories Ltd.
Generic for: Accolate - Mefenamic Acid Capsules USP, 250 mg
Approved: November 19, 2010 - Micro Labs Limited
Generic for: Ponstel Capsules - Donepezil Hydrochloride Tablets 5 mg and 10 mg
Approved: November 26, 2010 - Ranbaxy Laboratories Limited
Generic for: Aricept Tablets - Levocetirizine Dihydrochloride Tablets 5 mg
Approved: November 26, 2010 - Synthon Pharmaceuticals, Inc.
Generic for: Xyzal - Topotecan Hydrochloride Injection 4 mg base/vial
Approved: November 29, 2010 - APP Pharmaceuticals, LLC; Fresenius Kabi
Generic for: Hycamtin
December
- Zolpidem Tartrate Extended-Release Tablets 12.5 mg
Approved: December 3, 2010 - Anchen Pharmaceuticals, Inc.
Generic for: Ambien CR Tablets, 12.5 mg - Levofloxacin Ophthalmic Solution 0.5%
Approved: December 20, 2010 - Apotex Inc.; Nexus Pharmaceuticals, Inc.; Akorn Inc.
Generic for: Quixin Ophthalmic Solution - Dutasteride Capsules 0.5 mg
Approved: December 21, 2010 - Barr Laboratories, Inc.
Generic for: Avodart Capsules - Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg (base) and 100 mg (base)
Approved: December 28, 2010 - Impax Laboratories, Inc.; Mylan Pharmaceuticals, Inc.
Generic for: Doryx Tablets