Justice Department· Rule· 87 FR 32991
Schedules of Controlled Substances: Placement of Ganaxolone in Schedule V
effective in 0d·comments close in 30d
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…
Owner check — Regulated-substance action: affected handlers should confirm licensing, inventory, shipping, and compliance obligations.