Quick answers
- What is Interferon GAMMA-1B used for?
- The FDA-approved label (Actimmune, Horizon Therapeutics USA, Inc., March 30, 2026) says: “ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Interferon GAMMA-1B 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 Interferon GAMMA-1B?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Interferon GAMMA-1B been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Interferon GAMMA-1B?
- 1 company lists prescription products of Interferon GAMMA-1B in the FDA NDC Directory, including Horizon Therapeutics USA, Inc..
What Interferon GAMMA-1B is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for …
— FDA label: Actimmune, Horizon Therapeutics USA, Inc., effective March 30, 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 | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Actimmune |
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.
- Horizon Therapeutics USA, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103836 ACTIMMUNE | Horizon Therapeutics Ireland Dac | February 25, 1999 | 7, latest August 27, 2015 2015: Labeling · 2007: Supplement · 2005: Labeling |
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) | 240448, 751970 |
|---|---|
| SPL set ID of the quoted label | 5d0b1256-1981-4519-94f4-a4a2f98bd8a3 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA103836 |
| Active ingredients (FDA) | INTERFERON GAMMA-1B |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Actimmune, Horizon Therapeutics USA, Inc., effective March 30, 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 →