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Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V

scheduling · Rule · Interim final rule with request for comments. · Published 2020-01-31 · 85 FR 5557

Document

Document number
2020-01957
Federal Register citation
85 FR 5557
Type
Rule
Action
Interim final rule with request for comments.
Category
scheduling
Publication date
2020-01-31

Abstract

On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-(1- methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule V of the CSA.

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