FDA accepts Eliquis for review
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.
Qualitest receives FDA approval for Myzilra tablets
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.
Watson gets green light for generic Yaz
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.