General MedicationsORALStandard
KALYDECO
IVACAFTOR
Standard Dose
5.8MG/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KALYDECO is listed in Drugs@FDA under application 207925 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR Form and strength GRANULE;ORAL - 5.8MG/PACKET Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview KALYDECO is listed in Drugs@FDA under application 207925 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR Form and strength GRANULE;ORAL - 5.8MG/PACKET Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-17 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.