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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a cysteine conjugated ADC, where the mc-vc-PAB-MMAE linker/payload is conjugated to mAb intermediate, an immunoglobulin G1(IgG1) molecule;
Date Designated: 04/24/2023
Orphan Designation: Treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TORL Biotherapeutics, LLC
6100 Bristol Parkway
Culver, California 90230
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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