WASHINGTON, Aug. 26 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS.
The notice was published in the Federal Register on Aug. 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Registerof 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 informationsection is warranted. This notice corrects the applicable regulatory...