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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ecopipam hydrochloride
Date Designated: 07/21/2009
Orphan Designation: Symptomatic treatment of self injurious behaviors in patients with Lesch-Nyhan disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Emalex Biosciences, Inc.
1033 Skokie Bulevard, Suite 600
Northbrook, Illinois 60062
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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