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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: sarizotan
Date Designated: 07/07/2015
Orphan Designation: Treatment of Rett syndrome.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Newron Pharmaceuticals US, Inc.
89 Headquarter Plaza North
Suite 1438
Morristown, New Jersey 07960
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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