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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:  SEIZALAM
Date Designated:  02/04/2016
Orphan Designation:  Treatment of status epilepticus
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/14/2018 
Approved Labeled Indication:  SEIZALAM is indicated for the treatment of status epilepticus in adults.
Exclusivity End Date:    09/14/2025 
Exclusivity Protected Indication* :  SEIZALAM is indicated for the treatment of status epilepticus in adults.
Meridian Medical Technologies
6350 Stevens Forest Road
Suite 301
Columbia, Maryland 21046
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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