SOTATERCEPT-CSRK
SOTATERCEPT-CSRK is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand name including WINREVAIR. Available dosage forms: kit, injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- SOTATERCEPT-CSRK
- Brand Names
- WINREVAIR
- Application Number
- BLA761363
- Sponsor
- Merck Sharp & Dohme LLC
- NDC Codes
- 14
- Dosage Forms
- KIT, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- 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 )