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General MedicationsORALStandard

ALYFTREK

DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Standard Dose
125MG;50MG;EQ 10MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview ALYFTREK is listed in Drugs@FDA under application 218730 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM Form and strength TABLET;ORAL - 125MG;50MG;EQ 10MG BASE Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview ALYFTREK is listed in Drugs@FDA under application 218730 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM Form and strength TABLET;ORAL - 125MG;50MG;EQ 10MG BASE Sponsor VERTEX PHARMS INC Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.