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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: crenolanib besylate
Date Designated: 12/20/2010
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AROG Pharmaceuticals, LLC
Two Lincoln Centre
Suite 410
Dallas, Texas 75240
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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