First FDA-Approved Cannabis Drug Now Available in U.S.
THURSDAY, Nov. 1, 2018 -- The first cannabis-based medication approved by the U.S. Food and Drug Administration is now available by prescription nationwide.
Epidiolex is a twice-daily oral solution approved for use in patients age 2 years and older with two types of epileptic syndromes, Dravet syndrome and Lennox-Gastaut syndrome, CNN reported. The FDA approved the drug, made by GW Pharmaceuticals, in June.
"Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures," company CEO Justin Gover said in a written statement, CNN reported.
"Adequate and well-controlled clinical studies supported Epidiolex's approval, so prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes," FDA Commissioner Scott Gottlieb, M.D., said in a written statement.
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Posted: November 2018