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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: R-4-amino-3-(4-chlorophenyl)butanoic acid
Date Designated: 11/28/2008
Orphan Designation: Treatment of the behavorial abnormalities associated with fragile X syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Clinical Research Associates, LLC
160 Fifth Avenue
7th Floor
New York, New York 10010
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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