ganaxolone
Drug Details
- Generic Name
- ganaxolone
- Brand Names
- ZTALMY
- Application Number
- NDA215904
- Sponsor
- Immedica Pharma US Inc
- NDC Codes
- 1
- Dosage Forms
- SUSPENSION
- Routes
- ORAL
- Active Ingredients
- GANAXOLONE
Indications and Usage
1 INDICATIONS AND USAGE ZTALMY is 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. ZTALMY 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. ( 1 )