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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Aprotinin
Trade Name: Trasylol
Date Designated: 11/17/1993
Orphan Designation: For prophylactic use to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft surgery, and in selected cases of primary coronary artery bypass graft surgery where the risk of bleeding is especially high (impaired hemostasis) or where transfusion is unavailable or unacceptable.
Orphan Designation Status: Designated/Approved
Bayer Corporation
Pharmaceutical Division
400 Morgan Lane
West Haven, Connecticut 06516
United States

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

Marketing approved:

1 Generic Name: Aprotinin
Trade Name: Trasylol
Marketing Approval Date: 12/29/1993
Approved Labeled Indication:
Exclusivity End Date: 12/29/2000 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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