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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: stiripentol
Trade Name: Diacomit
Date Designated: 10/30/2008
Orphan Designation: Treatment of Dravet syndrome
Orphan Designation Status: Designated/Approved
Biocodex
7, avenue Gallieni
94250
Gentilly
France

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: stiripentol
Trade Name: Diacomit
Marketing Approval Date: 08/20/2018
Approved Labeled Indication: DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam.
Exclusivity End Date: 08/20/2025 
Exclusivity Protected Indication* :  DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam.
2 Generic Name: stiripentol
Trade Name: Diacomit
Marketing Approval Date: 07/14/2022
Approved Labeled Indication: 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
Exclusivity End Date: 07/14/2029 
Exclusivity Protected Indication* :  Treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months to less than 2 years of age and weighing 7 kg or more
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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