Generic Drug Approvals: October 2006
First Time Generic Approvals
- Metronidazole
Vaginal Gel, 0.75%
Approved: October 31, 2006 QLT USA, Inc.
Generic for: Metrogel Vaginal Gel - Colestipol Hydrochloride
Tablets, 1 g
Approved: October 24, 2006 Impax Laboratories, Inc.
Generic for: Colestid Tablets
Other Generic Approvals
- Milrinone Lactate
Injection, 1 mg (base)/mL; 5 mL Syringe
Approved: October 31, 2006 Gland Pharma Limited - Nicotine Polacrilex
Gum USP, (Mint-Flavor) OTC 2 mg and 4 mg (base)/piece
Approved: October 30, 2006 Perrigo R&D Company - Methylprednisolone
Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL
Approved: October 27, 2006 Sicor Pharmaceuticals, Inc. - Promethazine
Hydrochloride Suppositories USP, 12.5 mg and 25 mg
Approved: October 26, 2006 Taro Pharmaceuticals U.S.A., Inc. - Pravastatin Sodium
Tablets 10 mg, 20 mg, and 40 mg
Approved: October 23, 2006 Watson Laboratories, Inc., Genpharm Inc., Cobalt Pharmaceuticals, Inc., Dr. Reddy’s Laboratories Limited, Lek Pharmaceuticals d.d., Apotex Inc. - Zonisamide Capsules,
25 mg, 50 mg, and 100 mg
Approved: October 16, 2006 Zydus Pharmaceuticals USA,Inc. - Cefadroxil for Oral
Suspension USP, 250 mg/5 mL and 500 mg/5 mL
Approved: October 16, 2006 Orchid Healthcare - Valproic Acid
Syrup (Valproic Acid Oral Solution, USP), 250 mg/5 mL
Approved: October 13, 2006 Vintage Pharmaceuticals, LLC - Ranitidine Tablets
USP, 150 mg and 300 mg
Approved: October 13, 2006 Interpharm Inc. - Gabapentin Tablets,
100 mg, 300 mg, and 400 mg
Approved: October 10, 2006 Apotex Inc. - Ribavirin Tablets,
200 mg
Approved: October 3, 2006 Sandoz Inc. - Citalopram Hydrobromide
Tablets, 10 mg (base), 20 mg (base), and 40 mg (base)
Approved: October 3, 2006 Invagen Pharmaceuticals, Inc. - Meloxicam Tablets,
7.5 mg and 15 mg
Approved: October 2, 2006 Aurobindo Pharma Limited
