FDAsafety guidance72% confidence
FDA AP — MALARONE PEDIATRIC (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
Application NDA021078. Sponsor: GLAXOSMITHKLINE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ATOVAQUONE, PROGUANIL HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Oncology · Solid Tumors and CNS Tumors
- Sub-indication
- General
Related signal: Entrectinib Phase 1/2 Study in Pediatric Solid Tumors and CNS Tumors Initiated