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Vanda Pharma (VNDA) Completes Tasimelteon pre-NDA with FDA Unit

March 25, 2013 6:57 AM EDT Send to a Friend
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the company held a pre-NDA meeting with the Division of Neurology Products of the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder (Non-24). Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently there is no FDA approved treatment for Non-24.

At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing.

Based on this successful completion of the pre-NDA meeting, Vanda is targeting an NDA submission for tasimelteon in mid-2013.




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