FDAsafety guidance66% confidence
FDA AP — ADEMPAS (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Bayer; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA204819. Sponsor: BAYER HLTHCARE. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: RIOCIGUAT.
Supporting Context
- Therapeutic area
- Cardiology · Pulmonary Hypertension
- Sub-indication
- Hypertension
Related signal: FDA Accepts Supplement for ADEMPAS (Riociguat) by Bayer Healthcare