Acthar

Product manufactured by Mallinckrodt Ard Llc

Application Nr Approved Date Route Status External Links
NDA022432 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Acthar Gel Is Indicated As Monotherapy For The Treatment Of Infantile Spasms In Infants And Children Under 2 Years Of Age. ( 1.1 ) Acthar Gel Is Indicated For The Treatment Of Exacerbations Of Multiple Sclerosis In Adults. ( 1.2 ) Acthar Gel May Be Used For The Following Disorders And Diseases: Rheumatic; Collagen; Dermatologic; Allergic States; Ophthalmic; Respiratory; And Edematous State. ( 1.3 To 1.9 ) 1.1 Infantile Spasms Acthar Gel (Repository Corticotropin Injection) Is Indicated As Monotherapy For The Treatment Of Infantile Spasms In Infants And Children Under 2 Years Of Age. 1.2 Multiple Sclerosis Acthar Gel (Repository Corticotropin Injection) Is Indicated For The Treatment Of Acute Exacerbations Of Multiple Sclerosis In Adults. Controlled Clinical Trials Have Shown Acthar Gel To Be Effective In Speeding The Resolution Of Acute Exacerbations Of Multiple Sclerosis. However, There Is No Evidence That It Affects The Ultimate Outcome Or Natural History Of The Disease. 1.3 Rheumatic Disorders As Adjunctive Therapy For Short-Term Administration (To Tide The Patient Over An Acute Episode Or Exacerbation) In: Psoriatic Arthritis; Rheumatoid Arthritis, Including Juvenile Rheumatoid Arthritis (Selected Cases May Require Low-Dose Maintenance Therapy), Ankylosing Spondylitis. 1.4 Collagen Diseases During An Exacerbation Or As Maintenance Therapy In Selected Cases Of: Systemic Lupus Erythematosus, Systemic Dermatomyositis (Polymyositis). 1.5 Dermatologic Diseases Severe Erythema Multiforme, Stevens-Johnson Syndrome. 1.6 Allergic States Serum Sickness. 1.7 Ophthalmic Diseases Severe Acute And Chronic Allergic And Inflammatory Processes Involving The Eye And Its Adnexa Such As: Keratitis; Iritis, Iridocyclitis, Diffuse Posterior Uveitis And Choroiditis, Optic Neuritis, Chorioretinitis; Anterior Segment Inflammation. 1.8 Respiratory Diseases Symptomatic Sarcoidosis. 1.9 Edematous State To Induce A Diuresis Or A Remission Of Proteinuria In The Nephrotic Syndrome Without Uremia Of The Idiopathic Type Or That Due To Lupus Erythematosus.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Corticotropin

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