Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

6:56AM Vanda Pharma reports successful completion of pre-NDA meeting with FDA on tasimelteon for the treatment of non-24-hour disorder in the totally blind (VNDA) 3.95 : Co announced that it held a pre-NDA meeting with the Division of Neurology Products of the FDAto discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. 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.