FDA grants Mylan approval for generic Avalide application

PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals for its application for a generic version of Sanofi Aventis’ Avalide Tablets.

The tablets, generically known as irbesartan and hydrochlorothiazide, are used to treat hypertension. The application is among the 92 that Mylan has submitted to the FDA for approval.

Avalide had U.S. sales of about $288 million for the 12 months ended March 31, according to IMS Health.