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May 29, 2014
07:06 EDTINSYInsys Therapeutics submits Type II DMF to FDA for CBD API
Insys Therapeutics announced it has submitted a Type II Drug Master File, or DMF, to the FDA for its cannabidiol, or CBD, active pharmaceutical ingredient, or API, and has been issued DMF# 28255. Insys recently announced plans to advance development of its pharmaceutical CBD program for the treatment of epilepsy in children and adults.
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September 29, 2014
07:14 EDTINSYInsys Therapeutics receives FDA orphan drug designation for CBD
Insys Therapeutics announced that the FDA has granted orphan drug designation, or ODD, to its pharmaceutical cannabidiol, CBD, for the treatment of glioma, which comprises approximately eighty percent of all malignant brain tumors. The ODD includes pontine glioma, a devastating form of primary brainstem glioma.
September 26, 2014
10:03 EDTINSYInsys Therapeutics receives orphan status for glioma treatment
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