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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Oprelvekin
Trade Name: Neumega
Date Designated: 12/17/1996
Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia.
Orphan Designation Status: Designated/Approved
Genetics Institute, Inc.
87 Cambridge Park Drive
Cambridge, Massachusetts 02140
United States

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

Marketing approved:

1 Generic Name: Oprelvekin
Trade Name: Neumega
Marketing Approval Date: 11/25/1997
Approved Labeled Indication:
Exclusivity End Date: 11/25/2004 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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