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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Hemin
Trade Name: Panhematin
Date Designated: 03/16/1984
Orphan Designation: Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria.
Orphan Designation Status: Designated/Approved
Abbott Laboratories
Diagnostics Division
Abbott Park, Illinois 60064
United States

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

Marketing approved:

1 Generic Name: Hemin
Trade Name: Panhematin
Marketing Approval Date: 07/20/1983
Approved Labeled Indication:
Exclusivity End Date: 07/20/1990 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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