FDAsafety guidance66% confidence
FDA AP — LENALIDOMIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Biocon Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA201452. Sponsor: ARROW INTL. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LENALIDOMIDE.
Supporting Context
- Therapeutic area
- Oncology · Small Molecule
- Sub-indication
- General
Related signal: FDA Accepts Supplement for Lenalidomide by Biocon Pharma