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: temozolomide
Trade Name: Temodar
Date Designated: 10/05/1998
Orphan Designation: Treatment of recurrent malignant glioma.
Orphan Designation Status: Designated/Approved
Schering-Plough Research Institute
2000 Galloping Hill Rd.
Kenilworth, New Jersey 07033
United States

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

Marketing approved:

1 Generic Name: temozolomide
Trade Name: Temodar
Marketing Approval Date: 08/11/1999
Approved Labeled Indication: Treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine
Exclusivity End Date: 08/11/2006 
Exclusivity Protected Indication* :  
2 Generic Name: temozolomide
Trade Name: Temodar
Marketing Approval Date: 03/15/2005
Approved Labeled Indication: Treatment of adult patients with newly diagnosed glioblastoma multiforme concomitatly with radiotherapy and then as maintenance treatment
Exclusivity End Date: 03/15/2012 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-