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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 4-(2-Methylanilidocarbamoyl)-phenylacetyl-L-Citrullyl-L-Glutamyl-L-Seryl-L-Valyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-[N-(19-carboxy-1-oxononadecyl)-L-gamma-glutamyl]-L-Lysyl amide
Date Designated: 09/21/2026
Orphan Designation: treatment of osteogenesis imperfecta
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Zhongshan LaiBo RuiChen BioMedicine Co., Ltd.(RabPharma)
Suites 508-512?Building 2, Dezhong Plaza, No.1 East Exhibition Road, Torch Development Zone
Zhongshan City 528437
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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