Orexigen 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.
Orexigen and Takeda announce availability of Contrave tablets for patients Takeda Pharmaceutical, its wholly-owned subsidiary Takeda Pharmaceuticals U.S.A. and Orexigen Therapeutics jointly announced that Contrave extended-release tablets are now available to patients by prescription in pharmacies across the U.S.. Contrave is approved by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition.