← FDA DRUG APPROVALS

FDA NDA · NDA212273

TRIKAFTA

elexacaftor, tezacaftor, and ivacaftor

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA212273
TYPE
NDA
ORIGINAL APPROVAL
2019-10-21
LATEST ACTION
2026-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIKAFTA (COPACKAGED) · ReferencePrescription
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR 100MG,75MG,50MG, IVACAFTOR 150MG · TABLET · ORAL
TRIKAFTA (COPACKAGED) · ReferencePrescription
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR 50MG,37.5MG,25MG, IVACAFTOR 75MG · TABLET · ORAL

Approval history

2026-03-27Efficacy · Supplement 14 · priority — Medication Guide ↗AP
2026-03-17Labeling · Supplement 17 · 901 required — Letter ↗AP
2025-09-25Labeling · Supplement 15 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 13 · 901 required — Letter ↗AP
2024-12-20Efficacy · Supplement 12 · priority — Letter ↗AP
2023-08-03Labeling · Supplement 11 · standard — Letter ↗AP
2023-04-26Labeling · Supplement 9 · standard — Label ↗AP
2021-10-04Labeling · Supplement 8 · standard — Label ↗AP
2021-06-08Efficacy · Supplement 4 · priority — Letter ↗AP
2020-12-21Efficacy · Supplement 2 · priority — Letter ↗AP
2020-11-18Labeling · Supplement 1 · standard — Label ↗AP
2019-10-21Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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