FDA AmVaz review could take two months

Executive Summary

Agency's reevaluation of Dr. Reddy's AmVaz (amlodipine maleate) NDA approval should be completed within two months, FDA says in court filing. While preparing a response to Norvasc marketer Pfizer's scientific challenges to AmVaz NDA, "FDA became aware that a first-line reviewer made reference to certain studies of Pfizer's in the documentation of his review." FDA issued administrative stay of approval of the AmVaz 505(b)(2) NDA Feb. 5 pending reevaluation of the data source for the review (1"The Pink Sheet" Feb. 16, 2004, p. 24)...