FDAsafety guidance72% confidence
FDA AP — BAXFENDY (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
Regulatory Analysis
Application NDA219878. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: BAXDROSTAT.
Supporting Context
- Therapeutic area
- Endocrinology · Primary Aldosteronism
- Sub-indication
- General
Related signal: AstraZeneca's Phase III Trial of Baxdrostat in Primary Aldosteronism Underway