FDAsafety guidance83% confidence
FDA AP — BAXFENDY (ORIG)
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 NDA219878. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: BAXDROSTAT.
Supporting Context
- Therapeutic area
- Cardiology · PAH
- Sub-indication
- Hypertension
Related signal: Study on Riociguat's Impact on Right Heart Function in PAH and CTEPH