Acthar Gel (Autoinjector), Acthar Gel

Treats infantile spasms. NDA 8372, held by Mallinckrodt Ireland. Corticotropin.

As of Nov 13, 2026, NDA 8372 (Acthar Gel (Autoinjector), Acthar Gel), held by Mallinckrodt Ireland, was first approved by FDA on Apr 29, 1952, with 32 approved supplements and 0 published complete response letters.

First approved: Apr 29, 1952
Review: Standard
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. Acthar Gel may be used for the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous state. 1.1 Infantile Spasms

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Apr 29, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Acthar Gel (Autoinjector)40 UNITS/0.5ML · injectable;injection	Corticotropin	RxReference drug
Acthar Gel (Autoinjector)80 UNITS/ML · injectable;injection	Corticotropin	RxReference drug
Acthar Gel40 UNITS/ML · injectable;injection	Corticotropin	Discontinued
Acthar Gel80 UNITS/ML · injectable;injection	Corticotropin	RxReference drug

All 33 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 5, 2026	Supplement 88Labeling · Standard review	Approved	Label Letter
Feb 29, 2024	Supplement 74Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 29, 2021	Supplement 71Labeling · Standard review	Approved	Letter Label
Mar 2, 2021	Supplement 68Labeling · Standard review	Approved	Letter Label
Mar 26, 2019	Supplement 61Labeling · Standard review	Approved	Label Letter
Apr 26, 2018	Supplement 57Labeling · Standard review	Approved	Letter Label
Jul 31, 2017	Supplement 55Labeling · Standard review	Approved	None posted
Apr 19, 2016	Supplement 51Manufacturing · Standard review	Approved	None posted
Mar 14, 2016	Supplement 50Manufacturing · Standard review	Approved	None posted
Mar 11, 2016	Supplement 49Manufacturing · Standard review	Approved	None posted
Mar 4, 2016	Supplement 48Manufacturing · Standard review	Approved	None posted
Mar 24, 2015	Supplement 44Labeling · Standard review	Approved	Label Letter
Jan 17, 2014	Supplement 47Manufacturing · Standard review	Approved	None posted
Jul 5, 2012	Supplement 45REMS	Approved	Review Letter
Nov 6, 2002	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 15, 1999	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 15, 1998	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 5, 1994	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 26, 1993	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 22, 1992	Supplement 29Labeling	Approved	None posted
Mar 25, 1985	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 15, 1985	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 29, 1984	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 24, 1983	Supplement 25Labeling	Approved	None posted
Mar 26, 1981	Supplement 24Labeling	Approved	None posted
Jun 26, 1979	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 26, 1979	Supplement 21Labeling	Approved	None posted
Jun 26, 1979	Supplement 20Labeling	Approved	None posted
Jun 26, 1979	Supplement 18Labeling	Approved	None posted
Mar 14, 1978	Supplement 17Labeling	Approved	None posted
Oct 5, 1977	Supplement 16Labeling	Approved	None posted
Jun 1, 1977	Supplement 15Labeling	Approved	None posted
Apr 29, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8372
Drugs@FDA: Overview at FDA
Company: Mallinckrodt Ireland

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