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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fomepizole
Trade Name: Antizole
Date Designated: 12/22/1988
Orphan Designation: Treatment of methanol or ethylene glycol poisoning.
Orphan Designation Status: Designated/Approved
Par Pharmaceuticals, Inc
1 Ram Ridge Road
Chestnut Ridge, New York 10977
United States

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

Marketing approved:

1 Generic Name: fomepizole
Trade Name: Antizole
Marketing Approval Date: 12/04/1997
Approved Labeled Indication: As an antidote to ethylene glycol (antifreeze) poisoning, or for use in suspected ethylene glycol ingestion.
Exclusivity End Date: 12/04/2004 
Exclusivity Protected Indication* :  
2 Generic Name: fomepizole
Trade Name: Antizole
Marketing Approval Date: 12/08/2000
Approved Labeled Indication: Use for suspected or confirmed methanol poisoning, either alone or in combination with hemodialysis
Exclusivity End Date: 12/08/2007 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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