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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
Trade Name: Abraxane
Date Designated: 09/03/2009
Orphan Designation: Treatment of pancreatic cancer.
Orphan Designation Status: Designated/Approved
Abraxis BioScience, LLC
9225 Indian Creek Parkway, Suite 900
Overland Park, Kansas 66210
United States

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

Marketing approved:

1 Generic Name: paclitaxel protein-bound particles
Trade Name: Abraxane
Marketing Approval Date: 09/06/2013
Approved Labeled Indication: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
Exclusivity End Date: 09/06/2020 
Exclusivity Protected Indication* :  Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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