Mylan Inc. today announced that the company 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. This is the generic version of Avalide which is manufactured by Sanofi, and is a medication used to treat hypertension and congestive heart failure.
Avalide had U.S. sales of approximately $288 million for the last year, according to IMS Health.
Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.





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