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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Paclitaxel protein-bound particles for injection suspension
Date Designated: 10/01/2009
Orphan Designation: Treatment of stage IIb to IV melanoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 06/19/2015
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Celgene Corporation
400 Connell Drive
Suite 7000
Berkeley Heights, New Jersey 07922
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.