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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-HER2 monoclonal antibody-monomethyl auristatin E (MMAE) antibody-drug conjugate
Date Designated: 09/10/2018
Orphan Designation: Treatment of Gastric Cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
RemeGen, Ltd.
58 Middle Beijing Road
Yantai Economic & Technological Development Area, Yantai, Shandong

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.