Posted by Michael Wonder on 25 Aug 2016
Mallinckrodt receives FDA fast track designation for Synacthen Depot IND application
25 August 2016 - Expedites potential treatment for Duchenne muscular dystrophy.
Mallinckrodt today announced the U.S. FDA has granted the company's request for a fast track designation for its investigational new drug application for Synacthen Depot in the treatment of Duchenne muscular dystrophy.
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 auto-immune and inflammatory conditions, but has never been approved for use in patients in the U.S.
