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FEDERAL REGISTER · NOTICEJuly 2, 2025NOTICE — NO LEGAL EFFECT

Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGNot tagged
Document type
Notice
Agency
Health and Human Services Department
Published
July 2, 2025
Document number
2025-12343
Docket
FDA-2024-E-0209, FDA-2024-E-0210
ABSTRACT

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 12, 2025. The document, entitled "Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO," announced the determination of the regulatory review period for ELREXFIO (elranatamab-bcmm) for purposes of patent extension. The document was published with only one of two docket numbers. This document corrects that error.

Abstract as published in the Federal Register.

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