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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Methylnaltrexone
Date Designated: 06/17/1996
Orphan Designation: Treatment of chronic opioid-induced constipation unresponsive to conventional therapy.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Progenics Pharmaceuticals, Inc.
765 Old Saw Mill River Rd.
Tarrytown, New York 10591
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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