FDAapproval83% confidence
FDA Approves First Generics of Gilotrif (afatinib) Tablets
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Sandoz.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · VEGF Inhibitor
- Sub-indication
- General
Related signal: Sandoz submits ANDA for Tivozanib, marking a new generic entry