Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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.
Abstract as published in the Federal Register.
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