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news.The US Food and Drug Administration (FDA) has accepted for filing Insys Therapeutics' new drug application (NDA) for its Dronabinol Oral Solution, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol (THC).
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The agency has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 01 April 2016 for a decision on this NDA and it reflects a Standard Review by the FDA.
In the NDA, the company is seeking approval from FDA for anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Insys Therapeutics president and chief executive officer Michael Babich said: "We are very pleased to have our NDA for Dronabinol Oral Solution filing accepted by the FDA.
"We believe Dronabinol Oral Solution can become an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS.
"We will continue to work closely with the FDA throughout the review process for the approval of this significant product."
The company is focused on developing and commercializing new drugs and drug delivery systems of therapeutic molecules that improve the quality of life of patients.
Clinical shortcomings of existing commercial products are being addressed the company by using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids.