General MedicationsORALStandard

ALYFTREK

DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Standard Dose

50MG;20MG;EQ 4MG 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 - 50MG;20MG;EQ 4MG 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 - 50MG;20MG;EQ 4MG 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.