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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Latrodectus immune F(ab)2
Date Designated: 06/18/2001
Orphan Designation: Treatment of black widow spider envenomations
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/08/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Instituto Bioclon, S.A. de C.V.
Tlalpan,
No. 4687 Colonia Toriello Guerra
Tlalpan
Mexico

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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