← FDA DRUG APPROVALS

FDA NDA · NDA203188

KALYDECO

ivacaftor

Sponsor: VERTEX PHARMS

APPLICATION
NDA203188
TYPE
NDA
ORIGINAL APPROVAL
2012-01-31
LATEST ACTION
2026-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KALYDECO · ReferencePrescription
IVACAFTOR 150MG · TABLET · ORAL

Approval history

2026-03-17Labeling · Supplement 44 · 901 required — Letter ↗AP
2025-09-25Labeling · Supplement 42 · standard — Letter ↗AP
2025-05-22Efficacy · Supplement 41 · priority — Letter ↗AP
2023-08-03Labeling · Supplement 40 · standard — Letter ↗AP
2023-05-03Labeling · Supplement 38 · standard — Label ↗AP
2020-12-21Efficacy · Supplement 34 · priority — Letter ↗AP
2020-09-24Efficacy · Supplement 33 · priority — Letter ↗AP
2019-04-29Efficacy · Supplement 29 · priority — Label ↗AP
2018-08-15Efficacy · Supplement 28 · priority — Letter ↗AP
2017-07-31Efficacy · Supplement 26 · priority — Label ↗AP
2017-05-17Efficacy · Supplement 19 · priority — Label ↗AP
2017-02-08Efficacy · Supplement 22 · standard — Letter ↗AP
2017-01-11Manufacturing (CMC) · Supplement 24 · standardAP
2016-05-20Manufacturing (CMC) · Supplement 20 · priorityAP
2015-11-24Manufacturing (CMC) · Supplement 9 · priorityAP
2015-09-01Manufacturing (CMC) · Supplement 18 · priorityAP
2015-03-09Manufacturing (CMC) · Supplement 10 · priorityAP
2015-03-04Labeling · Supplement 17 · standard — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 16 · priorityAP
2014-12-29Labeling · Supplement 15 · standard — Label ↗AP
2014-12-29Efficacy · Supplement 14 · priority — Label ↗AP
2014-12-11Manufacturing (CMC) · Supplement 13 · priorityAP
2014-11-10Manufacturing (CMC) · Supplement 12 · priorityAP
2014-07-29Manufacturing (CMC) · Supplement 11 · priorityAP
2014-06-13Labeling · Supplement 7 · standard — Letter ↗AP
2014-04-08Labeling · Supplement 8 · standard — Label ↗AP
2014-02-21Efficacy · Supplement 4 · priority — Label ↗AP
2013-12-13Manufacturing (CMC) · Supplement 3 · priorityAP
2013-06-03Manufacturing (CMC) · Supplement 2 · priorityAP
2012-08-28Labeling · Supplement 1 · 901 required — Label ↗AP
2012-01-31Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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