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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 Jan. 1, 2013, to the present.