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Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulator...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket Nos. FDA-2023-E-1548; FDA-2023-E-1550]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.

FOR FURTHER INFORMATION CONTACT:

Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

Correction

In the Federal Register of February 29, 2024 (89 FR 14880), on page 14881, second column, under II. Determination of Regulatory Review Period, the first two sentences of the section should be corrected to read as follows:

FDA has determined that the applicable regulatory review period for CAMZYOS is 2,722 days. Of this time, 2,266 days occurred during the testing phase of the regulatory review period, while 456 days occurred during the approval phase.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2025-16273 Filed 8-25-25; 8:45 am]

BILLING CODE 4164-01-P

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Federal Register Citation

Use this for formal legal and research references to the published document.

90 FR 41579

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“Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS,” thefederalregister.org (August 26, 2025), https://thefederalregister.org/documents/2025-16273/determination-of-regulatory-review-period-for-purposes-of-patent-extension-camzyos.