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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: midazolam
Trade Name: NAYZILAM
Date Designated: 10/20/2009
Orphan Designation: Rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. acute repetitive seizures, seizure clusters)
Orphan Designation Status: Designated/Approved
UCB, Inc.
1950 Lake Park Drive
Building 2100
Smyrna, Georgia 30080
United States

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

Marketing approved:

1 Generic Name: midazolam
Trade Name: NAYZILAM
Marketing Approval Date: 05/17/2019
Approved Labeled Indication: NAYZILAM is indicated for the 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 12 years of age and older.
Exclusivity End Date: 05/17/2026 
Exclusivity Protected Indication* :  NAYZILAM is indicated for the 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 12 years of age and older.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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