ARTICLE | Clinical News
Betrixaban regulatory update
October 31, 2016 7:00 AM UTC
Portola said it submitted to FDA an NDA for betrixaban as extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. The oral Factor Xa inhibitor has Fast Track designation from FDA for the indication. The company plans to submit an MAA to EMA by year end...