Duchenne Muscular Dystrophy: Marathon Pharmaceuticals Gets FDA Fast Track Designation

 

Marathon Pharmaceuticals, an Illinois-based company that manufactures and commercializes pharmaceutical products for rare diseases, announces January 19^th that Deflazacort receives the FDA’s Fast Track designation for Duchenne Muscular Dystrophy (DMD). Deflazacort gets FDA Orphan Drug Designation (ODD) in August 2013. Deflazacort is a glucorticoid used as an anti-inflammatory and immunosuppressant. A New Drug Application (NDA) is anticipated in early 2016.

Marathon Pharmaceuticals FDA ODD Database Record

Generic Name:	Deflazacort
Trade Name:	n/a
Date Designated:	08-16-2013
Orphan Designation:	Duchenne muscular dystrophy
Orphan Designation Status:	Designated
FDA Orphan Approval Status:	Not FDA Approved for Orphan Indication
Sponsor:	Marathon Pharmaceuticals, LLC 1033 Skokie Blvd., Suite 600 Northbrook, IL

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