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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: diazepam
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
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.

Marketing approved:

1 Generic Name: diazepam
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  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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