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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: gemcitabine intra-arterial infusion via the RenovoCath¿ RC120 catheter
Date Designated: 04/24/2018
Orphan Designation: Treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
RenovoRx
4546 El Camino Real
Suite 203
Los Altos, California 94022
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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