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FDA ApplicationResults for Orphan Drug Product Designations Search
Return to Orphan Designation Search Page
Result Number: 1
Generic Name: Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein (Mucin1- Glutathione S Transferase) Coupled To Oxidized Polymannose
Trade Name: Cvac(Tm)
Date Designated: 09-13-2010
Orphan Designation: Treatment of ovarian cancer.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Prima Biomed Ltd.
1233 High Street
Suite 1
Armadale, Victoria 3143
AUSTRALIA
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http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=315510
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