Generic Product News

Published Online: Thursday, October 15, 2009

Glycopyrrolate Tablets USP, 1 mg and 2 mg

Marketed by: Ranbaxy Pharmaceuticals Inc (Jacksonville, FL), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL)

Compared to: Robinul 1 mg and Robinul Forte Tablets, 2 mg, respectively (Sciele Pharma Inc)

Indication: Ranbaxy Pharmaceuticals Inc announced that RLL has received approval from the FDA to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg. The Ranbaxy formulations are bioequivalent and have the same therapeutic effect as that of the reference-listed drug Robinul 1 mg and Robinul Forte Tablets 2 mg, respectively. Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Dosage Form: Tablets: 1 and 2 mg

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Divalproex Sodium Extended-Release Tablets

Marketed by: Teva Pharmaceuticals (North Wales, PA)

Compared to: Depakote ER Tablets (Sanofi-Aventis)

Indication: Teva Pharmaceuticals announced the introduction and availability of Divalproex Sodium Extended-Release Tablets. The product is AB-rated and bioequivalent to Depakote ER Tablets. Divalproex Sodium Extended- Release Tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features; monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures; and prophylaxis of migraine headaches.

Dosage Form: Tablets: 500 mg

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Hyoscyamine Sulfate Extended-Release Tablets

Marketed by: Paddock Laboratories Inc (Minneapolis, MN)

Compared to: Levsin (Alaven Pharmaceutical LLC)

Indication: Paddock Laboratories Inc announced the introduction of Hyoscyamine Sulfate Extended-Release Tablets. The product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm, and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. It also is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis, and other functional gastrointestinal disorders.

Dosage Form: Tablets: 0.375 mg

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Torsemide Tablets

Marketed by: Camber Pharmaceuticals Inc (Piscataway, NJ)

Compared to: Demadex (Roche Laboratories Inc)

Indication: Camber Pharmaceuticals announced the introduction and availability of Torsemide Tablets. Camber Torsemide Tablets are AB-rated and bioequivalent to Demadex Tablets. Camber Torsemide Tablets are available in 5-, 10-, 20-, and 100-mg strengths in bottle sizes of 100. Torsemide Tablets are indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. The tablets are also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.

Dosage Form: Tablets: 5, 10, 20, and 100 mg

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