FDAsafety guidance83% 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 memantine.
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 Brain Tumors
- Sub-indication
- Ild
Related signal: Memantine Pilot Study for Cognitive Protection in Pediatric Brain Tumor Patients Undergoing Radiation