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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

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.