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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Small molecule allosteric inhibitor of the phosphodiesterase-4D enzyme
Date Designated: 03/26/2018
Orphan Designation: Treatment of Fragile X Syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Tetra Discovery Partners, Inc.
38 Fulton Street West
Suite 303
Grand Rapids, Michigan 49503
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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