sotatercept
sotatercept is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: liquid.
Drug Details
- Generic Name
- sotatercept
- Brand Names
- N/A
- Application Number
- Sponsor
- SAMSUNG BIOLOGICS Co., Ltd.
- NDC Codes
- 1
- Dosage Forms
- LIQUID
- Routes
- N/A
- Active Ingredients
- SOTATERCEPT-CSRK
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 )