Health and Human Services Department Docket FDA-2023-N-0964 Notice

2023-06576: GlaxoSmithKline Intellectual Property Development Ltd. England; Announcement of the Revocation of the Biologics License for BLENREP

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Summary

The Food and Drug Administration (FDA or Agency) is announcing the revocation of the biologics license for BLENREP (belantamab mafodotin-blmf) powder for injection. GlaxoSmithKline Intellectual Property Development Ltd. England (GSK) requested withdrawal (revocation) of the biologics license and has waived its opportunity for a hearing.

The agency’s own summary, as published.

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