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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-coated buttress
Date Designated: 07/15/2014
Orphan Designation: For use as local administration at the time of curative surgery in the treatment of stage 0 to III non-small cell lung cancer.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cook Biotech Incorporated
1425 Innovation Place
West Lafayette, Indiana 47906
United States

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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.