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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Antivenin, crotalidae polyvalent immune Fab (ovine)
Trade Name: CroFab
Date Designated: 01/12/1994
Orphan Designation: Treatment of envenomations inflicted by North American crotalid snakes.
Orphan Designation Status: Designated/Approved
Protherics, Inc.
1207 17th Ave. S., Suite 103
Nashville, Tennessee 37212
United States

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

Marketing approved:

1 Generic Name: Antivenin, crotalidae polyvalent immune Fab (ovine)
Trade Name: CroFab
Marketing Approval Date: 10/02/2000
Approved Labeled Indication: Treatment of minimal and moderate North American Crotalidae envenomation
Exclusivity End Date: 10/02/2007 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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