← FDA DRUG APPROVALS

FDA NDA · NDA217660

TRIKAFTA

elexacaftor, tezacaftor, and ivacaftor

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA217660
TYPE
NDA
ORIGINAL APPROVAL
2023-04-26
LATEST ACTION
2026-03-27
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

TRIKAFTA (COPACKAGED) · ReferencePrescription
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR 80MG, 60MG, 40MG, IVACAFTOR 59.5MG · GRANULE · ORAL
TRIKAFTA (COPACKAGED) · ReferencePrescription
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR 100MG, 75MG, 50MG, IVACAFTOR 75MG · GRANULE · ORAL

Approval history

2026-03-27Efficacy · Supplement 8 · priority — Medication Guide ↗AP
2026-03-17Labeling · Supplement 10 · 901 required — Letter ↗AP
2025-09-25Labeling · Supplement 9 · standardAP
2024-12-20Labeling · Supplement 5 · 901 required — Label ↗AP
2024-12-20Efficacy · Supplement 3 · priority — Label ↗AP
2023-08-03Labeling · Supplement 2 · standard — Letter ↗AP
2023-04-26Type 3 - New Dosage Form · 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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