Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218730
Company: VERTEX PHARMS INC

• Medication Guide

Products on NDA 218730

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALYFTREK	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	50MG;20MG;EQ 4MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ALYFTREK	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	125MG;50MG;EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218730

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2024	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218730s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218730Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218730Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2025	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218730s002lbl.pdf

Labels for NDA 218730

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2025	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218730s002lbl.pdf
09/25/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218730s002lbl.pdf
12/20/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218730s000lbl.pdf