Product News

Carvedilol Tablets

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to:
Coreg (SmithKline Beecham)

Indication:
October 5, 2007—Teva Pharmaceuticals announced the introduction and availability of Carvedilol Tablets. Carvedilol is an alpha-beta-adrenergic blocking agent indicated for the treatment of left ventricular dysfunction following myocardial infarction in clinically stable patients and hypertension. Dosages may vary and should be individualized and monitored during up-titration. For left ventricular dysfunction following myocardial infarction, the patient should be started at 6.25 mg twice daily and increased to 12.5 mg, then 25 mg twice daily after intervals of 3 to 10 days. For the treatment of hypertension, the patient should be started at 6.25 mg twice daily and increased if needed for blood pressure control to 12.5 mg, then 25 mg twice daily over intervals of 1 to 2 weeks.

Dosage Form:
Tablets: 3.125, 6.25, 12.5, and 25 mg

For More Information:
www.tevausa.com

Bethanechol Chloride Tablets, USP

Marketed by:
Amneal Pharmaceuticals LLC (Paterson, NJ)

Compared to:
Urecholine (Barr Laboratories)

Indication:
November 27, 2007—Amneal Pharmaceuticals announced that, after an accelerated FDA-approval process, it received FDA approval to manufacture Bethanechol Chloride Tablets, USP in strengths of 5, 10, 25, and 50 mg, effective November 21, 2007. Bethanechol Cl is an AA-Rated, therapeutically equivalent alternative to Urecholine (a trademark of Barr Laboratories). Amneal is one of the very first companies to submit an Abbreviated New Drug Application in the FDA's new, optional eCTD/QBR/QOS format. Bethanechol Cl tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Dosage Form:
Tablets: 5, 10, 25, and 50 mg

For More Information:
www.amneal.com

Clarithromycin for Oral Suspension, USP

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

Compared to:
Biaxin Granules, 125 mg/5 mL and 250 mg/5mL (Abbott Laboratories)

Indication:
October 2, 2007— Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received final FDA approval to manufacture and market Clarithromycin for Oral Suspension, USP, 125 mg/5 mL and 250 mg/5 mL. Ranbaxy is the first company to have been granted a generic approval for the oral suspension form along with Clarithromycin Tablets. Clarithromycin for oral suspension, USP, is indicated for the treatment of mild-to-moderate infections caused by susceptible designated microorganisms in a number of conditions including pharyngitis/tonsillitis, community-acquired pneumonia, uncomplicated skin and skin structure infections, and disseminated mycobacterial infections.

Dosage Form:
Oral suspension: 125 mg/5 mL and 250 mg/5 mL

For More Information:
www.ranbaxyusa.com

Hydrochlorothiazide Tablets, USP

Marketed by:
Heritage Pharmaceuticals Inc (Edison, NJ)

Compared to:
Hydrodiuril (Merck & Co Inc)

Indication:
October 29, 2007—Heritage Pharmaceuticals Inc launched Hydrochlorothiazide Tablets, USP (HCTZ). The product is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. HCTZ is also indicated in the management of hypertension. This product is AB-rated and available in 100- and 1000-count bottles.

Dosage Form:
Tablets: 25 and 50 mg

For More Information:
www.heritagepharma.com
866-901-1230