FDAsafety guidance72% confidence
FDA AP — MALARONE PEDIATRIC (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Novartis.
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 · Pediatric
- Sub-indication
- Ild
Related signal: Feasibility Study on Sensory Changes in Pediatric Oncology Patients Undergoing Treatment