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Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US
Author: Jennie Crabbe
Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US.
The US FDA approved the supplemental new drug application (sNDA) for the SelfJect in February 2024.
SelfJect provides a subcutaneous dose of Acthar gel and is designed to give adult patients, including those with dexterity issues, control of their administration. The color-coded device is pre-filled with Acthar gel, available in 40 USP units/0.5 mL (green label) and 80 USP units/1.0 mL (purple label) versions.
Extracted from the pituitary glands of pigs, the drug is a purified preparation of adrenocorticotropic hormone (ACTH) for patients with a range of chronic and acute inflammatory and autoimmune conditions.
Acthar gel will continue to be available as an injection with a vial and syringe, the company said, particularly for those patients who require doses other than 40 or 80 units.
Acthar gel is FDA-approved for the ophthalmic indication of treatment of severe acute and chronic allergic and inflammatory processes involving the eye (keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation). Other indications include arthritis and multiple sclerosis.
