Insys receives FDA orphan drug designation for pharmaceutical cannabidiol Insys Therapeutics announced that the U.S. Food and Drug Administration has granted orphan drug designation to its pharmaceutical cannabidiol for the treatment of Lennox-Gastaut Syndrome, a rare pediatric-onset epilepsy. The company said, "We have the unique opportunity to test a controlled pharmaceutical CBD product for Lennox-Gastaut Syndrome, and our company is committed to advancing cannabinoid therapies that have the potential to provide significant medical benefits to patients across multiple indications. We expect to file an Investigational New Drug Application for CBD in 2H14."
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