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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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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 Jan. 1, 2013, to the present.