FDAsafety guidance72% confidence
FDA AP — RIOCIGUAT (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Merck Sharp & Dohme LLC.
Regulatory Analysis
Application ANDA211135. Sponsor: MSN. Submission status: AP. Submission type: SUPPL. Active ingredients: RIOCIGUAT.
Supporting Context
- Therapeutic area
- Cardiology · PAH
- Sub-indication
- Hypertension
Related signal: Study on Riociguat's Impact on Right Heart Function in PAH and CTEPH