FDA
20th December 2013

Meeting Announcement – ZONTIVITY (vorapaxar sulfate)

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).

Meeting Announcement – ZONTIVITY (vorapaxar sulfate)

January 15, 2014 8:00 a.m. to 5:30 p.m.: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Where:

FDA White Oak Campus
Building 31
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.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want to find out what happens during this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a summary of this meeting’s outcome!

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