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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: crotalidae immune F(ab')2 (equine)
Trade Name: Anavip
Date Designated: 01/29/2004
Orphan Designation: Treatment of envenomation by Crotaline snakes
Orphan Designation Status: Designated/Approved
Rare Disease Therapeutics, Inc.
12975 Brookprinter Place
Suite 170
Poway, California 92064
United States

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

Marketing approved:

1 Generic Name: crotalidae immune F(ab')2 (equine)
Trade Name: Anavip
Marketing Approval Date: 05/06/2015
Approved Labeled Indication: Management of adult and pediatric patients with North American rattlesnake envenomation
Exclusivity End Date: 05/06/2022 
Exclusivity Protected Indication* :  Management of adult and pediatric patients with North American rattlesnake envenomation
2 Generic Name: crotalidae immune F(ab')2 (equine)
Trade Name: Anavip
Marketing Approval Date: 04/01/2021
Approved Labeled Indication: For the management of adult and pediatric patients with North American Pit Viper envenomation
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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