Kalydeco

Treats cystic fibrosis (CF). NDA 203188, held by Vertex Pharms. Ivacaftor.

As of Nov 13, 2026, NDA 203188 (Kalydeco), held by Vertex Pharms, was first approved by FDA on Jan 31, 2012, with 30 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2012
Review: Priority
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


May 22, 2025	Supplement 41Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 21, 2020	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 24, 2020	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 29, 2019	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 15, 2018	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 31, 2017	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 17, 2017	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 8, 2017	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 29, 2014	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 21, 2014	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 31, 2012	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kalydeco150MG · tablet;oral	Ivacaftor	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Mar 17, 2026	Supplement 44Labeling	Approved	Label Letter
Sep 25, 2025	Supplement 42Labeling · Standard review	Approved	Letter Label
May 22, 2025	Supplement 41Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 3, 2023	Supplement 40Labeling · Standard review	Approved	Letter Label
May 3, 2023	Supplement 38Labeling · Standard review	Approved	Label Letter
Dec 21, 2020	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 24, 2020	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 29, 2019	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 15, 2018	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 31, 2017	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 17, 2017	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 8, 2017	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 11, 2017	Supplement 24Manufacturing · Standard review	Approved	None posted
May 20, 2016	Supplement 20Manufacturing · Priority review	Approved	None posted
Nov 24, 2015	Supplement 9Manufacturing · Priority review	Approved	None posted
Sep 1, 2015	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 9, 2015	Supplement 10Manufacturing · Priority review	Approved	None posted
Mar 4, 2015	Supplement 17Labeling · Standard review	Approved	Label Letter
Jan 5, 2015	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 29, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 29, 2014	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 11, 2014	Supplement 13Manufacturing · Priority review	Approved	None posted
Nov 10, 2014	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 29, 2014	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 13, 2014	Supplement 7Labeling · Standard review	Approved	Letter Label
Apr 8, 2014	Supplement 8Labeling · Standard review	Approved	Letter Label
Feb 21, 2014	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 13, 2013	Supplement 3Manufacturing · Priority review	Approved	None posted
Jun 3, 2013	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 28, 2012	Supplement 1Labeling	Approved	Label Letter
Jan 31, 2012	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 203188
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