JUN 28 EMDAC

On June 28, 2016, the Endocrinologic and Metabolic Drugs Advisory Committee will discuss supplemental new drug application (sNDA) 204629, empagliflozin (JARDIANCE) tablets, and sNDA 206111, empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. Announcement.