Schedules of Controlled Substances: Placement of Ganaxolone in Schedule V

Resumo

On March 18, 2022, the United States Food and Drug Administration approved a new drug application for ZTALMY, an oral suspension of ganaxolone, for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients two years of age and older. The Department of Health and Human Services provided the Drug Enforcement Administration with a scheduling recommendation to place ganaxolone and its salts in schedule V of the Controlled Substances Act. In accordance with the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, Drug Enforcement Administration is hereby issuing an interim final rule placing ganaxolone, including its salts in schedule V of the Controlled Substances Act.