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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: liposome encapsulated paclitaxel
Date Designated: 12/03/2014
Orphan Designation: Treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Benuvia Therapeutics, LLC
3950 N. Mays Street
Round Rock, Texas 78665
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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