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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (3S)-3-[({1-(2-Chlorobenzyl)-4-hydroxy-5-methyl-2-oxo-1,2-dihydropyridin-3yl}amino)carbonyl]amino-3-(4-methylphenyl)propanoic acid monosodium salt
Date Designated: 04/25/2016
Orphan Designation: For mobilization of hematopoietic stem cells
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aviara Pharmaceuticals, Inc/
3331 Green Tree Park
Houston, Texas 77027
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.