Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction

摘要

The Food and Drug Administration (FDA or the Agency) is correcting a notice that appeared in the Federal Register of July 13, 2022. The document determined the regulatory review period for ENSPRYNG. After review of a timely request for reconsideration by the applicant of the calculation of the applicable regulatory review period of the biologic product ENSPRYNG 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.