Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
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Issuing agencies
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 163 (Tuesday, August 26, 2025)</title>
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[Federal Register Volume 90, Number 163 (Tuesday, August 26, 2025)]
[Notices]
[Page 41579]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-E-1548; FDA-2023-E-1550]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CAMZYOS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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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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