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

概要

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 12, 2018, for the determination of the regulatory review period for the animal drug BRAVECTO. In accordance with the Court's order in Nissan Chemical Corp., et al. v. FDA, et al., No. 22-01598 (D.D.C), this document revises the SUPPLEMENTARY INFORMATION section of that notice by adjusting the start date of the testing phase for BRAVECTO. This notice supersedes the June 11, 2021, Federal Register document revising the February 12, 2018, notice.