Mallinckrodt Says FDA Grants SNDA For Acthar Gel Single-Dose Pre-Filled SelfJect Injector

(RTTNews) - Specialty pharma company Mallinckrodt plc (MNK), Friday announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application or SNDA for Acthar Gel Single-Dose Pre-Filled SelfJect Injector for the treatment of patients with inflammatory and autoimmune disorders.

The company stated that SelfJect, pre-filled with the prescribed dose of Acthar Gel in 40-unit or 80-unit versions, would be available in the U.S. in the second half of 2024.

Along with the device, the company also offers insurance coverage, commercial copay assistance, injection training services, and customized nurse assistance.