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March 25, 2013
06:57 EDTVNDAVanda reports successful completion of pre-NDA meeting with FDA on tasimelteon
Vanda Pharmaceuticals announced that the company held a pre-NDA meeting with the Division of Neurology Products of the FDA to discuss the regulatory path for filing a New Drug Application, or NDA, for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. 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.
News For VNDA From The Last 14 Days
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July 29, 2015
19:32 EDTVNDAOn The Fly: After Hours Movers
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16:21 EDTVNDAVanda raises FY15 Hetlioz, Fanapt sales to $100M-$115M from $95M-$110M
FY15 revenue consensus is $104.18M. Sees Hetlioz sales $40M-$45M. Raises Fanapt sales to $60M-$70M from $55M-$65M.
16:18 EDTVNDAVanda reports Q2 adjusted EPS (1c), may not compare to two estimates (29c)
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