Prescription medicine
Interferon gamma 1b Brand names: Actimmune
Interferon gamma 1b (Actimmune) is a prescription medicine with an FDA approval on record since 1999. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the interferon gamma 1b FDA label on DailyMed (effective March 30, 2026, Horizon Therapeutics USA, Inc.); the BLA 103836 record on Drugs@FDA; every interferon gamma 1b label on DailyMed.
Highlights of the record
FDA label of March 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD).
Forms and strengths
- 0.5ml
Injection (solution).
On the market
- Earliest approval on file
- February 25, 1999 Actimmune, Horizon Therapeutics Ireland Dac; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,395 through July 30, 2026
What is interferon gamma 1b used for?
From the label: indications and usageACTIMMUNE 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: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO)
FDA pharmacologic class: Interferon gamma.
Source: FDA drug label (ACTIMMUNE), Horizon Therapeutics USA, Inc., effective March 30, 2026 (SPL set 5d0b1256-1981-4519-94f4-a4a2f98bd8a3), via openFDA; the full label on DailyMed
Is there a generic for interferon gamma 1b (Actimmune)?
No generic interferon gamma 1b is approved (Drugs@FDA, October 8, 2026).
- 1999 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the interferon gamma 1b label say about other medicines?
The interferon gamma 1b label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Acetaminophen may also be used to ameliorate these effects. |
Source: FDA drug label (ACTIMMUNE), Horizon Therapeutics USA, Inc., effective March 30, 2026 (SPL set 5d0b1256-1981-4519-94f4-a4a2f98bd8a3), via openFDA; the full label on DailyMed
What do FAERS reports show for interferon gamma 1b?
The FDA Adverse Event Reporting System holds 1,395 reports that list interferon gamma 1b among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 202 are coded as a death and 539 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Interferon gamma 1b side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other