BioCentury
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FDA approves Merck's Zontivity

May 9, 2014 12:03 AM UTC

FDA approved an NDA for Zontivity vorapaxar from Merck & Co. Inc. (NYSE:MRK) to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs with no prior history of stroke, transient ischemic attack or bleeding in the head. The label includes a black box warning on the risk of bleeding. FDA's Cardiovascular and Renal Drugs Advisory Committee backed approval of the drug in January (see BioCentury, Jan. 27). ...