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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.