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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, linear terpolymeric macromolecule functionalized with carboxyl, phosphonic acid, and morpholine groups
Date Designated: 09/15/2026
Orphan Designation: treatment of calciphylaxis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Luofang Biotechnology (Shenzhen) Co., Ltd
No.1001 Xueyuan Road, Nanshan District
Room 2205, Block D2, Nanshan Zhiyuan
Shenzen, Guangdong Province 518071
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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