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 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
|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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