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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fixed set of four ribonucleic acid lipoplex (RNA-LPX) drug products (RBL001.3, RBL002.4, RBL003.3, RBL004.3) which code for four melanoma tumor-associated antigens
Date Designated: 09/15/2021
Orphan Designation: Treatment of stage IIB through IV melanoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BioNTech SE
An der Goldgrube 12, Mainz 55131
Germany

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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