General MedicationsORALStandard
GAVRETO
PRALSETINIB
Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview GAVRETO is listed in Drugs@FDA under application 214701 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient PRALSETINIB Form and strength CAPSULE;ORAL - 100MG Sponsor BLUEPRINT MEDICINES Submission history Latest submission status date: 2020-12-01 00:00:00.
Structured Monograph
Clinical summary
Approval overview GAVRETO is listed in Drugs@FDA under application 214701 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PRALSETINIB Form and strength CAPSULE;ORAL - 100MG Sponsor BLUEPRINT MEDICINES Submission history Latest submission status date: 2020-12-01 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.