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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide
Date Designated: 02/12/2015
Orphan Designation: Treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive, or ALK-positive colorectal cancer
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/07/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Genentech, Inc.
1 DNA Way
MS#241A
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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