New Drug Approvals


Betrixaban:PRT-54021, PRT-021, MK-4448, PRT-054021

N- (5- chloro-2-pyridyl) -2 – [[4 – [(dimethylamino) methyl] benzoyl] amino] -5 – methoxy – benzamide

CAS 330942-05-7

MW 451.91, C23H22ClN5O3

Venous Thromboembolism (VTE)

Millennium INNOVATOR

Takeda Pharmaceutical Co Ltd

Lee’s Pharmaceutical Holdings (Hong Kong) Ltd; Portola Pharmaceuticals Inc…DEVELOPERS

Ever since post was written now, FDA approval on June 23rd, 2017

The U.S. Food and Drug Administration (FDA) has approved betrixaban for the prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who are at risk for thromboembolic complications (related to limited mobility or other risk factors for VTE). Betrixaban is now the fifth FDA-approved oral anticoagulant on the market.

The decision was based on data from the phase III APEX trial, a double-blind, international study that randomized 7,513 patients to receive either extended-duration betrixaban (betrixaban 160 mg orally on day 1, then 80…

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