Is Corticotropin legal in the US?
Yes. Acthar Gel is FDA approved for seizures in babies under two and multiple sclerosis flare-ups, and a second brand is approved too.
Corticotropin is FDA-approved as Acthar Gel (repository corticotropin injection), first approved in 1952. The current label lists infantile spasms in children under two, acute exacerbations of multiple sclerosis in adults, and a set of older indications in rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory and edematous conditions. ANI Pharmaceuticals' Purified Cortrophin Gel, approved in 1954, is a second FDA-approved corticotropin product.
Yes. Acthar Gel has been approved since 1952. The infantile spasms use was formally approved in 2010. The label covers a long list of inflammatory conditions from the era before lab-made steroids. A second product, Purified Cortrophin Gel, has been approved since 1954. 324
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Citations
- Baram 1996, Pediatrics: high-dose corticotropin versus prednisone for infantile spasms, randomized blinded study pubmed.ncbi.nlm.nih.gov
- Acthar Gel prescribing information (manufacturer) acthar.com
- FDA label, 2021: Acthar Gel (repository corticotropin injection) accessdata.fda.gov
- Drugs@FDA: Acthar Gel (NDA 008372) approval record accessdata.fda.gov
Reference information only, not medical advice. Drawn from the Corticotropin article, fact-checked against the cited sources. No dosing anywhere on this site.