Friday, 10 April 2015

» Santhera Pharmaceuticals receives FDA fast track designation for Raxone/Catena Action Duchenne

» Santhera Pharmaceuticals receives FDA fast track designation for Raxone/Catena Action Duchenne: "Santhera Pharmaceuticals receives FDA fast track designation for Raxone/Catena (idebenone) for the treatment of Duchenne Muscular Dystrophy.

“We are very pleased that the FDA has granted Fast Track designation for Raxone/Catena which further underscores the unmet medical need for effective treatments for patients with DMD” commented Thomas Meier PhD CEO of Santhera. “On the basis of the positive data from our Phase III trial with Raxone/Catena in DMD we have started to prepare a New Drug Application and plan to meet with the FDA in the coming weeks to discuss our NDA dossier in a pre-NDA meeting.”More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=112438#.VSaOvSLF8bU#ixzz3Wp8uen6L"



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