The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) split 12-11 on a vote that data presented from the safety study, EMPA-REG OUTCOME, provided substantial evidence that Jardiance (empagliflozin, Boehringer Ingelheim Pharmaceuticals GmbH/Eli Lilly and Co.) reduced cardiovascular mortality in the study population. The data were reviewed in relation to proposed label expansions for Jardiance and Synjardy (empagliflozin and metformin hydrochloride) tablets.