Actimmune

For severe. BLA 103836, held by Horizon Therapeutics Ireland Dac. Interferon Gamma-1b.

As of Nov 13, 2026, BLA 103836 (Actimmune), held by Horizon Therapeutics Ireland Dac, was first approved by FDA on Feb 25, 1999, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 25, 1999
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 18, 2004	Supplement 5033Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 10, 2000	Supplement 1001Efficacy (new indication or use) · Priority review	Approved	Letter
Feb 25, 1999	Original applicationNew molecular entity	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Actimmune100UG/0.5ML · vial; single-use	Interferon Gamma-1b	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 27, 2015	Supplement 5182Labeling · Standard review	Approved	Letter Label
Jan 26, 2007	Supplement 5098	Approved	Label Letter
Sep 13, 2005	Supplement 5071Labeling · Standard review	Approved	None posted
Nov 24, 2004	Supplement 5050Labeling · Standard review	Approved	Letter Label
Mar 18, 2004	Supplement 5033Efficacy (new indication or use) · Priority review	Approved	None posted
May 9, 2003	Supplement 5017Labeling · Standard review	Approved	None posted
Feb 10, 2000	Supplement 1001Efficacy (new indication or use) · Priority review	Approved	Letter
Feb 25, 1999	Original applicationNew molecular entity	Approved	None posted

Identifiers

Application: BLA 103836
Drugs@FDA: Overview at FDA
Company: Horizon Therapeutics Ireland Dac

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