PHARMACY

FDA accepts Eliquis for review

BY Allison Cerra

NEW YORK and PRINCETON, N.J. — A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

Bristol-Myers Squibb and Pfizer said their investigational compound Eliquis (apixaban) was accepted for review and granted a priority-review designation. The companies submitted the application to the agency after completing two phase-3 trials, which examined the efficacy and safety of Eliquis among about 24,000 patients.

The Prescription Drug User Fee Act goal for the drug is set for March 28, 2012.


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PHARMACY

Qualitest receives FDA approval for Myzilra tablets

BY Allison Cerra

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

The generic drug maker announced approval of Myzilra tablets (levonorgestrel and ethinyl estradiol tablets, USP) in the 0.05-mg/0.03-mg, 0.075-mg/0.04-mg and 0.125-mg/0.03-mg (28-day triphasic regimen) strengths.

U.S. sales for Myzilra tablets totaled approximately $34.4 million for the 12 months ended Sept. 30, according to IMS Health.


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Watson gets green light for generic Yaz

BY Allison Cerra

PARSIPPANY, N.J. — Watson Pharmaceuticals subsidiary Watson Labs has received regulatory approval for a generic oral contraceptive.

Watson Labs said its abbreviated new drug application for Vestura (3-mg drospirenone and 0.02-mg ethinyl estradiol) was approved by the Food and Drug Administration.

Watson currently is involved in patent litigation with Bayer concerning the product, which is a generic version of Bayer’s Yaz oral contraceptive product.


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