First-Time Generic Drug Approvals: June 2010
- 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
- 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
Approved: June 18, 2010 - APP Pharmaceuticals, LLC
Generic for: Azactam for Injection