💊FDA Corrects Regulatory Review Period for ELREXFIO Patent
Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The correction of the regulatory review period for ELREXFIO affects patent extension timelines, influencing market entry for competitors and impacting future revenue streams for businesses in the pharmaceutical sector. Compliance with corrected docket numbers is essential for legal documentation.