Product News

Pharmacy Times, Volume 0, 0

Carvedilol Tablets

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Coreg (SmithKline Beecham)

Indication:

October 5, 2007—Teva Pharmaceuticals announcedthe introduction and availability of CarvedilolTablets. Carvedilol is an alpha-beta-adrenergicblocking agent indicated for the treatment of leftventricular dysfunction following myocardial infarctionin clinically stable patients and hypertension.Dosages may vary and should be individualized andmonitored during up-titration. For left ventriculardysfunction following myocardial infarction, thepatient should be started at 6.25 mg twice dailyand increased to 12.5 mg, then 25 mg twice dailyafter intervals of 3 to 10 days. For the treatment ofhypertension, the patient should be started at 6.25mg twice daily and increased if needed for bloodpressure control to 12.5 mg, then 25 mg twice dailyover 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 Pharmaceuticalsannounced that, after an accelerated FDA-approvalprocess, it received FDA approval to manufactureBethanechol Chloride Tablets, USP in strengths of 5,10, 25, and 50 mg, effective November 21, 2007.Bethanechol Cl is an AA-Rated, therapeutically equivalentalternative to Urecholine (a trademark of BarrLaboratories). Amneal is one of the very first companiesto submit an Abbreviated New Drug Applicationin the FDA's new, optional eCTD/QBR/QOS format.Bethanechol Cl tablets are indicated for the treatmentof acute postoperative and postpartum nonobstructive(functional) urinary retention and for neurogenicatony 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, awholly owned subsidiary of Ranbaxy LaboratoriesLimited (RLL), announced that RLL has receivedfinal FDA approval to manufacture and marketClarithromycin for Oral Suspension, USP, 125 mg/5mL and 250 mg/5 mL. Ranbaxy is the first companyto have been granted a generic approval for theoral suspension form along with ClarithromycinTablets. Clarithromycin for oral suspension, USP, isindicated for the treatment of mild-to-moderateinfections caused by susceptible designatedmicroorganisms in a number of conditions includingpharyngitis/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 Inclaunched Hydrochlorothiazide Tablets, USP (HCTZ).The product is indicated as adjunctive therapy inedema associated with congestive heart failure,hepatic cirrhosis, and corticosteroid and estrogentherapy. HCTZ is also indicated in the managementof hypertension. This product is AB-rated and availablein 100- and 1000-count bottles.

Dosage Form:

Tablets: 25 and 50 mg

For More Information:

www.heritagepharma.com

866-901-1230