Orkambi

Treats cystic fibrosis (CF). NDA 206038, held by Vertex Pharms Inc. Ivacaftor; Lumacaftor.

As of Nov 14, 2026, NDA 206038 (Orkambi), held by Vertex Pharms Inc, was first approved by FDA on Jul 2, 2015, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 2, 2015
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Dec 13, 2024	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 25, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 28, 2016	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 2, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Orkambi125MG;200MG · tablet;oral	Ivacaftor; Lumacaftor	RxReference drug
Orkambi125MG;100MG · tablet;oral	Ivacaftor; Lumacaftor	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Mar 17, 2026	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 25, 2025	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 13, 2024	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 3, 2023	Supplement 17Labeling · Standard review	Approved	Letter Label
Sep 2, 2022	Supplement 16Labeling · Standard review	Approved	Label Letter
Aug 15, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 25, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 28, 2016	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 6, 2016	Supplement 6Labeling · Standard review	Approved	Letter
Aug 5, 2016	Supplement 4Manufacturing · Standard review	Approved	None posted
May 18, 2016	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 6, 2016	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 18, 2016	Supplement 2Manufacturing · Priority review	Approved	None posted
Jul 2, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 206038
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