• 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: immunoglobulin G degrading enzyme of Streptococcus pyogenes
Date Designated: 09/10/2015
Orphan Designation: Prevention of antibody mediated organ rejection in solid organ transplant patients.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hansa Medical AB
Scheelevägen 22, P. O. Box 785
SE-220 07

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.