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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: L-Lysinamide,N2,N6-bis(L-lysylglycyl-L-valyl-L-seryl-L-leucyl-L-seryl-L-tyrosyl-L-arginyl)-hexa-acetate salt
Date Designated: 09/18/2019
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TCM Biotech International Corp.
24F-8, No. 97
Sec. 1, Xintai 5th Rd., Xizhi Dist.
New Taipei City , Taiwan
Taiwan

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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