FDAsafety guidance66% confidence
FDA AP — AVAPRO (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Sanofi; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA020757. Sponsor: SANOFI AVENTIS US. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: IRBESARTAN.
Supporting Context
- Therapeutic area
- Cardiovascular · Antihypertensive
- Sub-indication
- General
Related signal: FDA Accepts Supplemental Application for AVAPRO by Sanofi