FDAapproval95% confidence
CDER proposes to withdraw approval of TAVNEOS
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to B BRAUN; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Nutritional Support · Parenteral Nutrition
- Sub-indication
- General
Related signal: FDA Approval Letter for Dextrose 5% in Plastic Container