How is the regulatory review period for an animal drug determined?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

For animal drugs where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase begins on the date of the submission of the administrative NADA.

As stated in MPEP 2757: “To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase, as defined by 35 U.S.C. 156(g)(4)(B)(ii), begins on the date of the submission of the administrative NADA.” This determination was established in the case of Wyeth Holdings Corp. v. Sebelius.