Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

6:55AM Vanda Pharma announces submission to FDA of a New Drug Application for tasimelteon for the treatment of non-24-hour disorder in the totally blind (VNDA) 9.20 : Co announced the submission of a New Drug Application (NDA) to the FDA for tasimelteon, a circadian regulator. Vanda is seeking FDA approval of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. Tasimelteon was developed to address a significant unmet medical need, the treatment of Non-24, for which there are currently no FDA approved products. "The data demonstrates that tasimelteon is able to reset the master body clock and synchronize the melatonin and cortisol circadian rhythms, resulting in significant clinical benefits to patients".