The committee will discuss new drug application (NDA) 204886, vorapaxar sulfate, proposed trade name ZONTIVITY, 2.5 milligram tablets, submitted by Merck Sharp & Dohme Corp., Inc., for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI).
January 15, 2014 8:00 a.m. to 5:30 p.m.: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The committee will discuss new drug application (NDA) 204886, vorapaxar sulfate, proposed trade name ZONTIVITY, 2.5 milligram tablets, submitted by Merck Sharp & Dohme Corp., Inc., for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI). The applicant also proposes that ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.
Please click HERE for the current roster of the Cardiovascular and Renal Drugs Advisory Committee.
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