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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.
News For INSY From The Last 14 Days
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October 16, 2014
09:02 EDTINSYInsys Therapeutics weakness creates buying opportunity, says JMP Securities
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October 15, 2014
18:26 EDTINSYOn The Fly: After Hours Movers
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16:34 EDTINSYInsys Therapeutics receives DEA approval to produce pharmaceutical Cannabidiol
Insys Therapeutics announced that its FDA inspected and Drug Enforcement Agency approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol. The company has also been granted a quota to produce 15kg of CBD in 2014 and expects a larger quota in 2015 for its continued clinical studies. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned. Insys held a pre-IND meeting with the FDA in September 2014 regarding its development program for CBD in pediatric patients suffering from Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of pediatric epilepsy. Insys projects to file an IND in December 2014 for these indications. Babich also noted that Insys has compared its pharmaceutical CBD, which is synthetically produced, with plant-derived CBD obtained from the National Institute on Drug Abuse (NIDA), and found both materials contain an identical chemical structure. "We are pleased that testing in our laboratories has confirmed our long-standing belief that our pharmaceutical CBD is the chemical structure of plant-derived CBD and we believe our purity levels will provide consistent material in the clinical programs," Babich concluded.
16:31 EDTINSYInsys Therapeutics provides update on Dronabinol Oral Solution NDA
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