FDAsafety guidance66% confidence
FDA AP — THALIDOMIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Bristol-Myers; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA213267. Sponsor: NATCO. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: THALIDOMIDE.
Supporting Context
- Therapeutic area
- Oncology · Immunomodulator
- Sub-indication
- General
Related signal: FDA Acceptance of Supplemental Application for Thalidomide by Bristol-Myers