• 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: miltefosine
Date Designated: 06/19/2017
Orphan Designation: Treatment of granulomatous amebic encephalitis (GAE)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Profounda, Inc.
5790 Hoffner Avenue
Suite 507
Orlando, Florida 32822
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.
-
-