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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: polifeprosan 20 with carmustine
Trade Name: Gliadel
Date Designated: 12/13/1989
Orphan Designation: Treatment of malignant glioma.
Orphan Designation Status: Designated/Approved
Guilford Pharmaceuticals, Inc.
6611 Tributary Street
Baltimore, Maryland 21224
United States

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

Marketing approved:

1 Generic Name: polifeprosan 20 with carmustine
Trade Name: Gliadel
Marketing Approval Date: 09/23/1996
Approved Labeled Indication: As an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated
Exclusivity End Date: 09/23/2003 
Exclusivity Protected Indication* :  
2 Generic Name: polifeprosan 20 with carmustine
Trade Name: Gliadel
Marketing Approval Date: 02/25/2003
Approved Labeled Indication: Expanding the indication to include patients with malignant glioma undergoing primary surgical resection.
Exclusivity End Date: 02/25/2010 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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