oral suspension, CXX Initial U.S. Approval
ganaxolone oral suspension is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older
facts about ganaxolone oral suspension
Approval Date: 3/18/2022
Proprietary Name: Ztalmy
Active Ingredient(s): ganaxolone
FDA-approved use: To treat seizures in cyclindependent kinase-like 5 deficiency disorder
Dosage Form: Oral Suspension
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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