💊FDA Notice on CAMZYOS Patent Extension and Review Period
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice involves a correction to the regulatory review period for CAMZYOS, which affects patent extensions. Changes in regulatory review timelines can influence market strategies and financial planning for businesses involved in the pharmaceutical and biotech sectors, impacting their competitive approach and potential revenue streams associated with patent protections.