FDAsafety guidance66% confidence
FDA Approves First Generics of Gilotrif (afatinib) Tablets
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Teva; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Cardiovascular · Hypertension
- Sub-indication
- Hypertension
Related signal: FDA Approves Supplemental NDA for ZIAC by Teva