Trikafta (Copackaged)

Treats cystic fibrosis (CF). NDA 212273, held by Vertex Pharms Inc. Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor.

As of Nov 13, 2026, NDA 212273 (Trikafta (Copackaged)), held by Vertex Pharms Inc, was first approved by FDA on Oct 21, 2019, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 21, 2019
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 6 ) or results in production of CFTR protein. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Mar 27, 2026	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Letter Medication Guide
Dec 20, 2024	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 8, 2021	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 21, 2020	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 21, 2019	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Trikafta (Copackaged)100MG,75MG,50MG; 150MG · tablet;oral	Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor	RxReference drug
Trikafta (Copackaged)50MG,37.5MG,25MG; 75MG · tablet;oral	Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Mar 27, 2026	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Letter Medication Guide
Mar 17, 2026	Supplement 17Labeling	Approved	Label Letter
Sep 25, 2025	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 20, 2024	Supplement 13Labeling	Approved	Letter Label
Dec 20, 2024	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 3, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 26, 2023	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 4, 2021	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 8, 2021	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 21, 2020	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 18, 2020	Supplement 1Labeling · Standard review	Approved	Label Letter
Oct 21, 2019	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 212273
Drugs@FDA: Overview at FDA
Company: Vertex Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters