FDAsafety guidance65% 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 AstraZeneca's Baxfendy Receives US Approval for Hypertension as First-in-Class T.
Regulatory Analysis
Application NDA219878. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: BAXDROSTAT.
Supporting Context
- Therapeutic area
- Cardiology · Hypertension
- Sub-indication
- Hypertension
Related signal: AstraZeneca's Baxfendy Receives US Approval for Hypertension as First-in-Class Treatment
Source
FDA document
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