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General MedicationsORALStandard

ORKAMBI

IVACAFTOR; LUMACAFTOR

Standard Dose
188MG/PACKET;150MG/PACKET
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 211358 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR; LUMACAFTOR Form and strength GRANULE;ORAL - 188MG/PACKET;150MG/PACKET 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 211358 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IVACAFTOR; LUMACAFTOR Form and strength GRANULE;ORAL - 188MG/PACKET;150MG/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.