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Generics makers roll out new products.

NEW YORK -- Several generic drugs have won Food and Drug Administration approval for new products, including the first generic version of 3M Co.'s MetroGel-Vaginal (metronidazole vaginal gel).

The agency approved QLT USA Inc.'s metronidazole vaginal gel 0.75% for bacterial vaginosis, a condition that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina.

QLT challenged certain patents for MetroGel-Vaginal and is eligible for 180 days of generic drug exclusivity.

Metronidazole is an antibiotic effective against anaerobic (lacking oxygen) bacteria.

IMPAX Laboratories Inc. has won FDA approval for its abbreviated new drug applications (ANDAs) for generic versions of Urecholine tablets (bethanechol chloride tablets USP), 5 mg, 10 rag, 25 mg and 50 mg.

Odyssey Pharmaceuticals Inc. markets Urecholine for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Sales of the branded and generic versions of Urecholine tablets were about $33 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.

IMPAX' ANDA for a generic version of Colestid tablets (colestipol hydrochloride tablets), 1 gram, was also approved. The FDA also awarded the company first-to-file status and 180-day market exclusivity.

Pharmacia & Upjohn Co. (Pfizer Inc.) markets the 1-gram tablet as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDLC) who do not respond adequately to the diet. Total brand sales of Colestid tablets, 1 gram, in the U.S. were $20 million for the 12 months ended August 31, 2006, according to Wolters Kluwer Health.

Par Pharmaceutical Cos. announced that its partner, Toronto-based Genpharm Inc., has received final FDA approval for its ANDA for pravastatin 10-mg, 20-mg, and 40-mg tablets. Pravastatin is the generic version of Bristol-Myers Squibb Co.'s Pravachol, which is used for treatment of certain hyperlipidemias.

In other generics industry news, Actavis U.S. has started to distribute glipizide ER tablets across the country. Glipizide ER tablets are used to treat type 2 diabetes, particularly in people whose diabetes cannot be controlled through diet alone. Glipizide ER tablets are the authorized generic version of Pfizer's Glucotrol XL tablets.

Acquired by Actavis from Andrx Pharmaceuticals Inc. as part of a Federal Trade Commission divestiture requirement, Actavis' product is AB-rated to Glucotrol XL tablets. Glipizide ER tablets are available in 2.5-mg, 5-mg, and 10-mg strengths. Total annual sales of glipizide ER tablets from all suppliers in the U.S. were about $195.4 million for the 12 months ended June 2006, according to IMS Health.

Also, Perrigo Co. has won tentative approval for its ANDA for ciclopirox topical solution 8% (nail lacquer). Final approval is subject to the September 18, 2007, expiration of the patent for the reference listed drug, Penlac nail lacquer, which is distributed by sanofi-aventis'_Dermik Laboratories.

Penlac is indicated for mild to moderate fungal infections of the fingernails and toenails and had sales of $125 million for the year ended August 2006, according to data from Wolters Kluwer.
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Publication:Chain Drug Review
Date:Nov 20, 2006
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