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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Alpha-tocopherol quinone
Date Designated: 03/28/2006
Orphan Designation: Treatment of inherited mitochondrial respiratory chain diseases
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Penwest Pharmaceuticals Company
39 Old Ridgebury Road
Suite 11
Danbury, Connecticut 06810
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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