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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Butyrylcholinesterase
Date Designated: 09/30/1992
Orphan Designation: Treatment of post-surgical apnea.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shire Laboratories Inc.
1550 East Gude Drive
Rockville, Maryland 20850
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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