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Vanda Pharma (VNDA) Submits Tasimelteon NDA to U.S. FDA

May 31, 2013 6:56 AM EDT Send to a Friend
Vanda Pharmaceuticals Inc. (VANDA) (Nasdaq: VNDA) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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.

Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and who therefore cannot entrain (synchronize) their master body clock to the 24-hour day.




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