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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
Date Designated:  05/08/2006
Orphan Designation:  Treatment of bouts of increased seizure activity in selected refractory patients with epilepsy who are on stable regimens of anti-epileptic drugs and who require intermittent use of midazolam
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
UCB, Inc
1950 Lake Park rive
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.