Cumberland Pharmaceuticals Receives FDA Fast Track Designation for DMD Heart Disease Therapy.

Cumberland Pharmaceuticals has received FDA Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. This designation allows for more frequent communication with the FDA and the opportunity to submit portions of an application for marketing approval on a rolling basis. Cumberland requested Fast Track Designation to streamline the regulatory pathway for ifetroban for DMD heart disease.