Mallinckrodt (MNK) Granted FDA Fast Track Designation for Synacthen IND as DMD Treatment
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Mallinckrodt Receives FDA Fast-Track Designation for Synacthen® Depot IND Application
August 25, 2016 7:30 AM EDTCHESTERFIELD, United Kingdom, Aug. 25, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions,... More
