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Duchenne Muscular Dystrophy: Marathon Pharmaceuticals Gets FDA Fast Track Designation

January 22, 2015

 

Marathon Pharmaceuticals, an Illinois-based company that manufactures and commercializes pharmaceutical products for rare diseases, announces January 19th 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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Please Note: “Chemicals in Flasks by Joe Sullivan (Flickr) [CC-BY-2.0] | Wikimedia Commons.

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