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 |
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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 |
Sponsor: |
BioNTech SE An der Goldgrube 12, Mainz 55131 Germany The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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