General MedicationsORALStandard
ORKAMBI
IVACAFTOR; LUMACAFTOR
Standard Dose
125MG;100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ORKAMBI is listed in Drugs@FDA under application 206038 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR; LUMACAFTOR Form and strength TABLET;ORAL - 125MG;100MG Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview ORKAMBI is listed in Drugs@FDA under application 206038 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR; LUMACAFTOR Form and strength TABLET;ORAL - 125MG;100MG 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.