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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Diazepam viscous solution for rectal administration
Trade Name:  Diastat
Date Designated:  02/25/1992
Orphan Designation:  For the management of selected, refractory, patients with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/29/1997 
Approved Labeled Indication:  
Exclusivity End Date:    07/29/2004 
Exclusivity Protected Indication* :  
Valeant Pharmaceuticals
3300 Hyland Avenue
Costa Mesa, California 92626
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.