Search Orphan Drug Designations and Approvals
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Generic Name: | diazepam | |||||||||||||
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Trade Name: | Libervant | |||||||||||||
Date Designated: | 11/10/2016 | |||||||||||||
Orphan Designation: | Treatment of selected, refractory patients with epilepsy who are on stable regimens of antiepileptic drugs (AED) and who require intermittent use of diazepam to control bouts of increased seizure activity (acute repetitive seizures) | |||||||||||||
Orphan Designation Status: | Designated/Approved | |||||||||||||
Sponsor: |
Aquestive Therapeutics 30 Technology Drive South Warren, New Jersey 07059 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | diazepam |
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Trade Name: | Libervant | |
Marketing Approval Date: | 04/26/2024 | |
Approved Labeled Indication: | acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient¿s usual seizure pattern in patients with epilepsy 2 to 5 years of age | |
Exclusivity End Date: | TBD | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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