• 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:  hydroxyurea
Date Designated:  03/16/2015
Orphan Designation:  Treatment of symptomatic sickle cell disease in pediatric patients, less than 17 years of age.
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Ebelle D'Ebelle Pharmaceuticals LLC
5 Witherwood Drive
Hamburg, New Jersey 07419
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.