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June 11, 2014
06:31 EDTOREXOrexigen receives three month extension of FDA NB32 review
Orexigen announced that the FDA has extended its review of the resubmitted New Drug Application for NB32, the company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act action date has been set for September 11. The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.
News For OREX From The Last 14 Days
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March 26, 2015
19:16 EDTOREXOn The Fly: After Hours Movers
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14:24 EDTOREXOrexigen says EC grants marketing authorization for Mysimba
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11:38 EDTOREXOrexigen management to meet with Leerink
Meetings to be held in Boston April 1- 2 hosted by Leerink.

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