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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (3S)-3-[(2S)-2-({N-[2-tert-butyl)phenyl]carbamoyl}carbonylamino) propanoylamino]-4-oxo-5-(2,3,5,6-tetrafluorophenoxy) pentanoci acid
Date Designated: 08/19/2003
Orphan Designation: Treatment of patients undergoing solid organ transplantation.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pfizer Global Research and Development
50 Pequot Avenue
New London, Connecticut 06320
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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