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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: gemfibrozil and vitamin A
Date Designated: 12/06/2017
Orphan Designation: Treatment of neuronal ceroid lipofuscinoses
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Polaryx Therapeutics, Inc.
140 East Ridgewood Avenue
Suite 415, South Tower
Paramus, New Jersey 07652
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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