Quick answers
- What is Ivacaftor used for?
- The FDA-approved label (Kalydeco, Vertex Pharmaceuticals Incorporated, March 23, 2026) says: “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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ivacaftor have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ivacaftor?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ivacaftor been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ivacaftor?
- 1 company lists prescription products of Ivacaftor in the FDA NDC Directory, including Vertex Pharmaceuticals Incorporated.
What Ivacaftor is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 […]. …
— FDA label: Kalydeco, Vertex Pharmaceuticals Incorporated, effective March 23, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Granule · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Kalydeco |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Vertex Pharmaceuticals Incorporated6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA203188 KALYDECO | Vertex Pharms | January 31, 2012 | 30, latest March 17, 2026 2026: Labeling · 2025: Labeling · 2025: Efficacy |
| NDA207925 KALYDECO | Vertex Pharms Inc | March 17, 2015 | 13, latest March 17, 2026 2026: Labeling · 2025: Labeling · 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kalydeco, Vertex Pharmaceuticals Incorporated, effective March 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →