Quick answers
- What is Iptacopan used for?
- The FDA-approved label (Fabhalta, Novartis Pharmaceuticals Corporation, July 16, 2026) says: “FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Iptacopan have a boxed warning?
- Yes. The FDA label for Fabhalta has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Iptacopan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Iptacopan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Iptacopan?
- 1 company lists prescription products of Iptacopan in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation.
What Iptacopan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. …
— FDA label: Fabhalta, Novartis Pharmaceuticals Corporation, effective July 16, 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.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Fabhalta |
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.
- Novartis Pharmaceuticals Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA218276 FABHALTA | Novartis | December 5, 2023 | 5, latest July 16, 2026 2026: Efficacy · 2025: Efficacy · 2024: 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
| RxCUI (RxNorm) | 2671074, 2671080 |
|---|---|
| SPL set ID of the quoted label | a76b5845-6e21-4d3b-ad07-cd8df1b60bee |
| FDA labels (SPL) | 1 |
| FDA applications | NDA218276 |
| Active ingredients (FDA) | IPTACOPAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fabhalta, Novartis Pharmaceuticals Corporation, effective July 16, 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 →