Santhera receives FDA Fast Track Designation for Raxone/Catena (idebenone)
"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."
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