Generic Times Product News

SEPTEMBER 01, 2006

Cefprozil Suspension

Marketed by: Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd (Princeton, NJ)

Compared to: Cefzil (Bristol-Myers Squibb Co)

Indication: June 30, 2006?Ranbaxy received approval from the FDA to manufacture and market Cefprozil for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL. Cefprozil suspension is indicated for the treatment of patients with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: pharyngitis/tonsillitis, otitis media, acute sinusitis, secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis, and uncomplicated skin and skin structure infections.

Dosage Form: Suspension: 125 mg/5 mL, 250 mg/5 mL

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Estradiol Transdermal Systems

Marketed by: Mylan Laboratories Inc (Pittsburgh, Pa)

Compared to: Climara Transdermal Systems (Berlex)

Indication: July 25, 2006?Mylan Laboratories announced that Mylan Technologies Inc's supplemental abbreviated new drug application (ANDA) for estradiol transdermal systems, 0.0375 and 0.06 mg/day, has received final approval from the FDA. Mylan will now market 6 strengths of estradiol transdermal systems. The product is indicated for the treatment of moderate-tosevere vasomotor symptoms associated with menopause. Mylan was the first company to file a supplemental ANDA for estradiol transdermal systems, 0.0375 and 0.06 mg/day.

Dosage Form: Transdermal patch: 0.025, 0.0375, 0.05, 0.06, 0.075, 0.1 mg/day

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Glipizide Tablets

Marketed by: Caraco Pharmaceutical (Detroit, Mich)

Compared to: Glucotrol (Pfizer Inc)

Indication: July 13, 2006?Caraco Pharmaceutical received final approval from the FDA to begin marketing and distributing its glipizide tablets. These tablets are indicated as an adjunct to diet for the control of hyperglycemia and the associated symptomatology in patients with non-insulin-dependent (type 2) diabetes mellitus.

Dosage Form: Tablets: 5 and 10 mg

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Meloxicam Tablets

Marketed by: Teva Pharmaceuticals (North Wales, Pa)

Compared to: Mobic (Boehringer Ingelheim)

Indication: July 20, 2006?Teva Pharmaceuticals announced the introduction and availability of meloxicam tablets for relief of the signs and symptoms of osteoarthritis.

Dosage Form: Tablets: 7.5 and 15 mg

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Simvastatin Tablets

Marketed by: Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd (Princeton, NJ)

Compared to: Zocor (Merck)

Indication: June 23, 2006?Ranbaxy received approval to manufacture and market simvastatin tablets, USP, 80 mg. They are indicated in the treatment of patients with CHD or at high risk of coronary heart disease, patients with hypercholesterolemia, and adolescent patients with heterozygous familial hypercholesterolemia.

Dosage Form: Tablets: 80 mg

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