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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: plasminogen, human-tvmh
Trade Name: Ryplazim
Date Designated: 03/05/2013
Orphan Designation: Treatment of hypoplasminogenemia, or type I plasminogen deficiency
Orphan Designation Status: Designated/Approved
ProMetic BioTherapeutics, Inc.
1330 Piccard Drive
Suite 201
Rockville, Maryland 20850
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: plasminogen, human-tvmh
Trade Name: Ryplazim
Marketing Approval Date: 06/04/2021
Approved Labeled Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
Exclusivity End Date: 06/04/2028 
Exclusivity Protected Indication* :  Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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