Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
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
Valeant Pharmaceuticals
3300 Hyland Avenue
Costa Mesa, California 92626
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Diazepam viscous solution for rectal administration
Trade Name: Diastat
Marketing Approval Date: 07/29/1997
Approved Labeled Indication:
Exclusivity End Date: 07/29/2004 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-