FDAsafety guidance72% confidence
FDA AP — VENETOCLAX (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Venetoclax.
Regulatory Analysis
Application ANDA214733. Sponsor: DR REDDYS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: VENETOCLAX.
Supporting Context
- Therapeutic area
- Oncology · Mantle Cell Lymphoma
- Sub-indication
- General
Related signal: Phase II Trial of Venetoclax and Rituximab in Older Patients With Mantle Cell Lymphoma