Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO; Correction
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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.
Full Text
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<title>Federal Register, Volume 90 Issue 125 (Wednesday, July 2, 2025)</title>
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[Federal Register Volume 90, Number 125 (Wednesday, July 2, 2025)]
[Notices]
[Page 29022]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12343]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ELREXFIO; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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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.
FOR FURTHER INFORMATION CONTACT: Jack Dan, Office of Regulatory Policy,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993,
240-402-6940.
SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, May 12,
2025 (90 FR 20177), in FR Doc. 2025-08256, the following corrections
are made:
1. On page 20177, in the second column of the header of the
document, ``Docket No. FDA-2024-E-0210'' is corrected to read ``Docket
Nos. FDA-2024-E-0209 and FDA-2024-E-0210.''
2. On page 20177, in the ADDRESSES section, in the third column
under Written/Paper Submissions, in the second and third lines of the
Instructions paragraph, ``Docket No. FDA-2024-E-0210'' is corrected to
read ``Docket Nos. FDA-2024-E-0209 and FDA-2024-E-0210.''
Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12343 Filed 7-1-25; 8:45 am]
BILLING CODE 4164-01-P
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