Briefing Summary: US FDA Posts Advisory Committee Materials About Daiichi Sankyo’s Savaysa (Edoxaban) for the Prevention of Stroke in Patients With Atrial Fibrillation – OCT 30, 2014 (CRDAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, October 30, 2014 Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Meeting. The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).