Mylan Inc. Announces Tentative FDA Approval for Generic Version of Antihypertensive Avalide(R) Tablets
PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. 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.
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Web site: http://www.mylan.com/