PITTSBURGH, June 16 PA-Mylan-FDA-approval
PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today
announced that its subsidiary, Mylan Pharmaceuticals Inc., has received
tentative approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for Irbesartan and Hydrochlorothiazide
Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg.
Irbesartan and Hydrochlorothiazide Tablets, indicated for the treatment of
hypertension, are the generic version of Sanofi Aventis' Avalide(R) Tablets,
which had U.S. sales of approximately $288 million for the 12 months ending
March 31, 2008, according to IMS Health.
Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are
potential first-to-file opportunities.
Mylan Inc., with a presence in more than 90 countries, ranks among the
leading diversified generic and specialty pharmaceutical companies in the
world. The company maintains one of the industry's broadest -- and highest
quality -- product portfolios, supported by a robust product pipeline; owns a
controlling interest in the world's second largest active pharmaceutical
ingredient manufacturer; and operates a specialty business focused on
respiratory and allergy therapies.
SOURCE Mylan Inc.
