FDAsafety guidance95% confidence
FDA AP — ENZALUTAMIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Sandoz; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA216068. Sponsor: SANDOZ. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: ENZALUTAMIDE.
Supporting Context
- Therapeutic area
- Not specified
- Sub-indication
- General
Related signal: Sandoz Inc. Submits ANDA219346 for Review by FDA