PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) todayannounced that its subsidiary, Mylan Pharmaceuticals Inc., has receivedtentative approval from the U.S. Food and Drug Administration (FDA) for itsAbbreviated New Drug Application (ANDA) for Irbesartan and HydrochlorothiazideTablets, 150 mg/12.5 mg and 300 mg/12.5 mg.
Irbesartan and Hydrochlorothiazide Tablets, indicated for the treatment ofhypertension, are the generic version of Sanofi Aventis' Avalide(R) Tablets,which had U.S. sales of approximately $288 million for the 12 months endingMarch 31, 2008, according to IMS Health.
Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which arepotential first-to-file opportunities.
Mylan Inc., with a presence in more than 90 countries, ranks among theleading diversified generic and specialty pharmaceutical companies in theworld. The company maintains one of the industry's broadest -- and highestquality -- product portfolios, supported by a robust product pipeline; owns acontrolling interest in the world's second largest active pharmaceuticalingredient manufacturer; and operates a specialty business focused onrespiratory and allergy therapies.
SOURCE Mylan Inc.