← FDA DRUG APPROVALS

FDA NDA · NDA206038

ORKAMBI

lumacaftor and ivacaftor

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA206038
TYPE
NDA
ORIGINAL APPROVAL
2015-07-02
LATEST ACTION
2026-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ORKAMBI · ReferencePrescription
IVACAFTOR 125MG, LUMACAFTOR 100MG · TABLET · ORAL
ORKAMBI · ReferencePrescription
IVACAFTOR 125MG, LUMACAFTOR 200MG · TABLET · ORAL

Approval history

2026-03-17Labeling · Supplement 20 · standard — Letter ↗AP
2025-09-25Labeling · Supplement 19 · standard — Letter ↗AP
2024-12-13Efficacy · Supplement 18 · priority — Label ↗AP
2023-08-03Labeling · Supplement 17 · standard — Letter ↗AP
2022-09-02Labeling · Supplement 16 · standard — Letter ↗AP
2018-08-15Labeling · Supplement 10 · standard — Label ↗AP
2018-01-25Efficacy · Supplement 7 · standard — Letter ↗AP
2016-09-28Efficacy · Supplement 5 · priority — Letter ↗AP
2016-09-06Labeling · Supplement 6 · standard — Letter ↗AP
2016-08-05Manufacturing (CMC) · Supplement 4 · standardAP
2016-05-18Labeling · Supplement 1 · standard — Label ↗AP
2016-04-06Manufacturing (CMC) · Supplement 3 · priorityAP
2016-03-18Manufacturing (CMC) · Supplement 2 · priorityAP
2015-07-02Type 1 - New Molecular Entity · Original · priority — Letter ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →