FDA Approves Cannabis-Based Drug for the First Time

August 6, 2018 | Strategic Insights for Ambulatory Care


​The U.S. Food and Drug Administration (FDA) announced on June 25, 2018, that it has approved a cannabis-based drug for the first time. The product is a twice-daily oral treatment for patients older than two years who have seizures associated with two rare and severe forms of epilepsy. Although FDA commissioner Scott Gottlieb, MD, hailed the approval as "an important medical advance," he also noted that this did not constitute an approval of marijuana. The drug is a purified from of cannabidiol (CBD), FDA said, which is one of the active chemicals in marijuana. A June 25, 2018, article from Business Insider suggests that the Drug Enforcement Administration must reschedule CBD from a Schedule 1 substance to a Schedule 2 or 3 substance, which would allow the drug to be sold in the United States.

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