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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: synthetic cyclic 8 amino acid analog of human unacylated ghrelin
Date Designated: 10/12/2017
Orphan Designation: Treatment of Prader-Willi syndrome (PWS)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Millendo Therapeutics, Inc.
301 North Main Street
Suite 100
Ann Arbor, Michigan 48104
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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