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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 buccal soluble film
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
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.