generic times product news

DECEMBER 01, 2006

Colestipol Hydrochloride Tablets 1 g

Marketed by: IMPAX Laboratories Inc (Hayward, Calif)

Compared to: Colestid (Pharmacia and Upjohn Co [Pfizer])

Indication: October 26, 2006—The FDA granted approval for IMPAX Laboratories' Colestipol Hydrochloride Tablets. The company also received first-to-file status and 180- day market exclusivity for this product. The tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet alone.

Dosage Form: Tablets: 1 g

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Ondansetron Injection USP

Marketed by: SICOR Pharmaceuticals Inc (Irvine, Calif), a wholly owned subsidiary of Teva Pharmaceuticals

Compared to: Zofran Injection (GlaxoSmithKline)

Indication: November 22, 2006—Teva Pharmaceuticals announced the introduction and availability of Ondansetron Injection USP. The product is AP-rated to Zofran Injection. The product is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. Ondansetron Injection is also indicated for the prevention of postoperative nausea and/or vomiting.

Dosage Form: 2 mg/mL, 4 mg in single-dose glass vials, 2 mg/mL, 40 mg in multiple-dose glass vials, and 32 mg/50 mL in flexible plastic containers.

For More Information: 800-729-9991

Glipizide ER Tablets

Marketed by: Actavis (Hafnarfjordur, Iceland)

Compared to: Glucotrol XL (Pfizer Inc)

Indication: November 6, 2006—Actavis announced the launch of glipizide ER tablets in the United States. These tablets are used as an adjunct to diet for the treatment of type 2 diabetes, particularly in patients whose diabetes cannot be controlled through diet alone.

Dosage Form: Tablets: 2.5, 5, and 10 mg

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Metronidazole Vaginal Gel, 0.75%

Marketed by: QLT USA Inc (Fort Collins, Colo)

Compared to: MetroGel-Vaginal (3M Pharmaceuticals)

Indication: November 1, 2006—The FDA approved the first generic version of metronidazole vaginal gel. The gel is indicated to treat bacterial vaginosis, a condition in women that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina. QLT USA Inc is eligible for 180 days of generic drug exclusivity.

Dosage Form: Gel: 70-g tube

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Sulfacetamide Sodium Topical Suspension USP 10%

Marketed by: Fougera, a division of Altana Inc (Melville, NY)

Compared to: Klaron (Dermik Laboratories)

Indication: November 17, 2006—Fougera, a specialty pharmaceutical manufacturer, announced that it received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10%. This generic formulation is comparable to Klaron, whose patent has expired. This product is indicated for the topical treatment of acne.

Dosage Form: 118-mL bottle

For More Information: 800-645-9833