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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
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.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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