Is Ivacaftor + Lumacaftor approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ivacaftor + Lumacaftor, including ORKAMBI (Prescription); ORKAMBI (Prescription).

Is Ivacaftor + Lumacaftor authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ivacaftor + Lumacaftor: Orkambi.

Active substances

Ivacaftor + Lumacaftor

US FDA 2
EMA 1
Health Canada 5

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ORKAMBI	125MG;200MG; 125MG;100MG	tablet · oral	VERTEX PHARMS INC	Prescription	2 Jul 2015
ORKAMBI	125MG/PACKET;100MG/PACKET; 188MG/PACKET;150MG/PACKET; 94MG/PACKET;75MG/PACKET	granule · oral	VERTEX PHARMS INC	Prescription	7 Aug 2018

EMA European Union — centrally authorised medicines

Orkambi Vertex Pharmaceuticals (Ireland) Limited · Authorised · authorised 19 Nov 2015 · ATC R07AX30

Therapeutic indication (EMA)

Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene. Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ORKAMBI	02451379	200 MG; 125 MG	TABLET · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
ORKAMBI	02463040	125 MG; 100 MG	TABLET · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
ORKAMBI	02483831	100 MG / SACHET; 125 MG / SACHET	GRANULES · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
ORKAMBI	02483858	150 MG / SACHET; 188 MG / SACHET	GRANULES · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
ORKAMBI	02537087	94 MG / SACHET; 75 MG / SACHET	GRANULES · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.