← FDA DRUG APPROVALS

FDA NDA · NDA218730

ALYFTREK

vanzacaftor, tezacaftor, and deutivacaftor

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA218730
TYPE
NDA
ORIGINAL APPROVAL
2024-12-20
LATEST ACTION
2026-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALYFTREK · ReferencePrescription
DEUTIVACAFTOR 125MG, TEZACAFTOR 50MG, VANZACAFTOR CALCIUM EQ 10MG BASE · TABLET · ORAL
ALYFTREK · ReferencePrescription
DEUTIVACAFTOR 50MG, TEZACAFTOR 20MG, VANZACAFTOR CALCIUM EQ 4MG BASE · TABLET · ORAL

Approval history

2026-03-27Efficacy · Supplement 1 · priority — Label ↗AP
2026-03-17Labeling · Supplement 3 · 901 required — Letter ↗AP
2025-09-25Labeling · Supplement 2 · standard — Label ↗AP
2024-12-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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