Prescription medicine
Sotatercept-csrk Brand names: Winrevair
Sotatercept-csrk (Winrevair) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sotatercept-csrk FDA label on DailyMed (effective August 12, 2026, Merck Sharp & Dohme LLC); the BLA 761363 record on Drugs@FDA; every sotatercept-csrk label on DailyMed.
Highlights of the record
FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageWINREVAIR™ 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) ].
Forms and strengths
Kit.
On the market
- Earliest approval on file
- March 26, 2024 Winrevair, Merck Sharp Dohme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,010 through July 30, 2026
What is sotatercept-csrk used for?
From the label: indications and usageWINREVAIR™ 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.
Conditions named in the indications of sotatercept-csrk's FDA labels, with every medicine labeled for each:
Source: FDA drug label (WINREVAIR), Merck Sharp & Dohme LLC, effective August 12, 2026 (SPL set 21693ee2-cd23-4137-ac67-066bb3a4a9b7), via openFDA; the full label on DailyMed
Is there a generic for sotatercept-csrk (Winrevair)?
No generic sotatercept-csrk is approved (Drugs@FDA, October 8, 2026).
- 2024 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for sotatercept-csrk?
The FDA Adverse Event Reporting System holds 5,010 reports that list sotatercept-csrk among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 208 are coded as a death and 2,060 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,250, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sotatercept-csrk side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other