The Food and Drug Administration licensed Epidyolex, a cannabidiol oral solution, on 19 January 2024 for Dravet syndrome from age two and tuberous sclerosis complex from age one. It is a prescription-only Category 2 controlled drug, imported by the FDA's own controlled-drugs plant, and is an add-on treatment when existing epilepsy drugs do not control seizures. The licence covered a medicine, not cannabis flower or general THC products.[1]
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References
- 衛生福利部食品藥物管理署 — 恩倍樂口服液 Epidyolex (cannabidiol) oral solution（衛部罕藥輸字第000094號）許可證號、發證日期 113-01-19、適應症
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