Generic Drug Approvals: January 2005
First Time Generic Approvals
- Fentanyl
Transdermal Systems 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and
100 mcg/hour
Approved: January 28, 2005 Company: Mylan Technologies, Inc.
Generic for: Duragesic Transdermal Systems
Treatment for: Chronic Pain - Desmopressin
Acetate Nasal Solution 0.01% (Nasal Spray)
Approved: January 27, 2005 Company: Apotex Inc.
Generic for: DDAVP Nasal Spray
Treatment for: Diabetes Insipidus and Nocturnal Enuresis - Levofloxacin
Tablets 750 mg
Approved: January 26, 2005 Company: Teva Pharmaceuticals USA
Generic for: Levaquin Tablets
Treatment for: Bacterial Infections - Clarithromycin
Extended-Release Tablets 1000 mg
Approved: January 26, 2005 Company: Ranbaxy Laboratories Limited
Generic for: Biaxin XL Extended-Release Tablets
Treatment for: Bacterial Infections - Estradiol
Transdermal System 0.025 mg/day and 0.075 mg/day
Approved: January 26, 2005 Company: Mylan Technologies, Inc.
Generic for: Climara
Treatment for: Menopausal Symptoms - Terconazole
Vaginal Cream 0.4%
Approved: January 19, 2005 Company: Taro Pharmaceuticals USA, Inc.
Generic for: Terazole 7 Vaginal Cream
Treatment for: Vaginal Candidiasis - Potassium Iodide
Oral Solution USP 65 mg/mL
Approved: January 12, 2005 Company: Fleming & Company, Pharmaceuticals
Generic for: Thyrosafe Tablets
Treatment for: Thyroid Protection in a Radiation Emergency
Other Generic Approvals
- Clindamycin Hydrochloride
Capsules USP 75 mg (Base), 150 mg (Base), and 300 mg
(Base)
Approved: January 31, 2005 Company: Zydus Pharmaceuticals USA, Inc. - Testosterone Cypionate
Injection USP 200 mg/mL; packaged in 1 mL and 10 mL
multiple-dose vials
Approved: January 31, 2005 Company: Paddock Laboratories - Atenolol
Tablets USP 25 mg, 50 mg, and 100 mg
Approved: January 28, 2005 Company: Zydus Pharmaceuticals USA, Inc. - Quinapril Hydrochloride Tablets 5
mg (Base), 10 mg (Base), 20 mg (Base), and 40 mg (Base)
Approved: January 28, 2004 Company: Par Pharmaceutical, Inc. - Sulfamethoxazole
and Trimethoprim Tablets USP 400 mg/80 mg and 800 mg/160
mg
Approved: January 27, 2005 Company: Interpharm, Inc.
