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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-(4-{3-(2-aminopyrimidin-4-yl)pyridin-2-yl]oxy}phenyl)-4-(4-methylthiophen-2-yl)phthalazin-1-amine bis-mesylate dihydrate
Date Designated: 10/21/2014
Orphan Designation: Treatment of ovarian cancer
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/06/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amgen, Inc.
One Amgen Center Drive
Mail Stop 17-2-B
Thousand Oaks, California 91320
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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