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FDA Approves Supplemental New Drug Application (sNDA) for the Acthar® Gel SelfJect™ Injector for Treatment of Autoimmune Conditions
The Food and Drug Administration (FDA) has approved Mallinckrodt’s supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (SelfJect) for people with chronic and acute inflammatory and autoimmune conditions, such as lupus.
Selfject is a new self-controlled, pre-filled injection for Acthar Gel, allowing patients or caregivers to self-administer the treatment. Acthar Gel contains a naturally occurring, highly purified hormone called ACTH which is designed to help your body produce its own natural steroid hormones, such as cortisol, and fight inflammation.
SelfJect is expected to launch in the U.S. in the second half of 2024. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.