SOTATERCEPT

FDA Drug Profile

Drug Details

Generic Name
SOTATERCEPT
Brand Names
N/A
Application Number
Sponsor
AbbVie Inc.
NDC Codes
1
Dosage Forms
LIQUID
Routes
N/A
Active Ingredients
SOTATERCEPT

Indications and Usage

1 INDICATIONS AND USAGE WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1) ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. ( 1 )