FDAsafety guidance66% confidence
FDA AP — KISQALI FEMARA CO-PACK (COPACKAGED) (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Novartis; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA209935. Sponsor: NOVARTIS. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: LETROZOLE, RIBOCICLIB SUCCINATE.
Supporting Context
- Therapeutic area
- Oncology · CDK4/6 Inhibitor
- Sub-indication
- General
Related signal: FDA Grants Priority Review for KISQALI Supplement by Novartis