General MedicationsORALStandard
VIJOICE
ALPELISIB
Standard Dose
50MG/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview VIJOICE is listed in Drugs@FDA under application 218466 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ALPELISIB Form and strength GRANULES;ORAL - 50MG/PACKET Sponsor NOVARTIS Submission history Latest submission status date: 2025-07-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview VIJOICE is listed in Drugs@FDA under application 218466 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALPELISIB Form and strength GRANULES;ORAL - 50MG/PACKET Sponsor NOVARTIS Submission history Latest submission status date: 2025-07-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.