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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.
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September 2, 2014
08:18 EDTOREXOrexigen receives new US patent related to NB32 intellectual property
Orexigen announced that the U.S. Patent and Trademark Office has issued a patent related to NB32, the Company's investigational medication being evaluated for weight loss. NB32 is a fixed-dose combination of naltrexone sustained release and bupropion SR. U.S. Patent No. 8,815,889 claims methods for treating insulin resistance using a composition including naltrexone and bupropion. The patent expires in 2024. If NB32 is approved for use in the United States, Orexigen expects the patent to be listed in the Orange Book maintained by the United States Food and Drug Administration. A counterpart application to this patent has issued in Europe and other international jurisdictions.

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