• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
Generic Name: 1-(4-{4-amino-7-[1-(2-hydroxyethyl)-1H-pyrazol-4-yl]thieno[3,2-c]pyridine-3-yl}phenyl)-3-(3-fluorophenyl)urea)
Date Designated: 07/28/2011
Orphan Designation: Treatment of acute myelogenous leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/16/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AbbVie, Inc.
1 N. Waukegan Road
North Chicago, Illinois 60064
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.