generic times product news
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 forIMPAX Laboratories' Colestipol Hydrochloride Tablets.The company also received first-to-file status and 180-day market exclusivity for this product. The tablets areindicated as adjunctive therapy to diet for the reductionof elevated serum total and low-density lipoproteincholesterol (LDL-C) in patients with primary hypercholesterolemia(elevated LDL-C) who do not respondadequately to diet alone.
Dosage Form:Tablets: 1 g
For More Information:www.impaxlabs.com
Ondansetron Injection USP
Marketed by:SICOR Pharmaceuticals Inc(Irvine, Calif), a wholly ownedsubsidiary of TevaPharmaceuticals
Compared to:Zofran Injection (GlaxoSmithKline)
Indication:November 22, 2006—Teva Pharmaceuticalsannounced the introduction and availability ofOndansetron Injection USP. The product is AP-rated toZofran Injection. The product is indicated for the preventionof nausea and vomiting associated with initialand repeat courses of emetogenic cancer chemotherapy.Ondansetron Injection is also indicated for theprevention of postoperative nausea and/or vomiting.
Dosage Form:2 mg/mL, 4 mg in single-dose glass vials, 2 mg/mL, 40mg in multiple-dose glass vials, and 32 mg/50 mL inflexible plastic containers.
For More Information:www.sicor.com800-729-9991
Glipizide ER Tablets
Compared to:Glucotrol XL (Pfizer Inc)
Indication:November 6, 2006—Actavis announced the launch ofglipizide ER tablets in the United States. These tabletsare used as an adjunct to diet for the treatment oftype 2 diabetes, particularly in patients whose diabetescannot be controlled through diet alone.
Dosage Form:Tablets: 2.5, 5, and 10 mg
For More Information:www.actavis.com
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 firstgeneric version of metronidazole vaginal gel. The gel isindicated to treat bacterial vaginosis, a condition inwomen that is characterized by vaginal discharge andresults from an overgrowth of bacteria in the vagina.QLT USA Inc is eligible for 180 days of generic drugexclusivity.
Dosage Form:Gel: 70-g tube
For More Information:www.qltinc.com
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, aspecialty pharmaceutical manufacturer,announced that it received FDA approval to bring tomarket the first generic Sulfacetamide Sodium TopicalSuspension USP 10%. This generic formulation is comparableto Klaron, whose patent has expired. Thisproduct is indicated for the topical treatment of acne.
Dosage Form:118-mL bottle
For More Information:www.fougera.com800-645-9833