• 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: Ivaltinostat
Date Designated: 01/03/2023
Orphan Designation: Treatment of Idiopathic Pulmonary Fibrosis.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Machaon Biotherapeutics, Inc.
70 Osongsaengmyeong 6-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do 28158
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.