Taro board member steps down
HAWTHORNE, N.Y. — Taro Pharmaceutical Industries announced that one of its board members has resigned.
The generic drug maker confirmed the resignation of Ilan Leviteh, effective Nov. 14. Leviteh stepped down as a director due to demands on his time relating to obligations to other companies, along with concern over fulfilling the increased time commitments required of the board in light of the recent offer from Sun Pharmaceutical Industries to purchase all of Taro’s issued and outstanding shares not currently held by Sun Pharma.
The company noted that Leviteh did not indicate any disagreement on any matter relating to the company’s operations, policies or practices.
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.