FDAsafety guidance72% confidence
FDA AP — SANDIMMUNE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to pediatric ITP patients.
Regulatory Analysis
Application NDA050574. Sponsor: NOVARTIS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CYCLOSPORINE.
Supporting Context
- Therapeutic area
- Hematology · Immune Thrombocytopenic Purpura
- Sub-indication
- General
Related signal: Study on Hemato-immunological Parameters in Immune Thrombocytopenic Purpura