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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Recombinant humanized anti-human epidermal growth factor receptor monoclonal antibody conjugated to monomethyl auristatin E
Date Designated: 09/20/2022
Orphan Designation: Treatment of patients with nasopharyngeal carcinoma (NPC)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Miracogen Inc.
Building 3, Suite 4E, No. 1238 Zhangjiang Rd.
Pudong District
Shanghai 201203

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.