• 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: pracinostat
Date Designated: 02/27/2014
Orphan Designation: Treatment of acute myeloid leulemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/26/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Helsinn Healthcare SA
P.O. Box 357
Pambio-Noranco, Lugano 6915

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.