stiripentol
Drug Details
- Generic Name
- stiripentol
- Brand Names
- Diacomit
- Application Number
- NDA207223
- Sponsor
- BIOCODEX, INC.
- NDC Codes
- 4
- Dosage Forms
- POWDER, FOR SUSPENSION, CAPSULE
- Routes
- ORAL
- Active Ingredients
- STIRIPENTOL
Indications and Usage
1 INDICATIONS AND USAGE DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more . There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. ( 1 )