United States v. Undetermined Quantities of Various Articles of Drug ... Equidantin Nitrofurantoin Suspension .... Appeal of Performance Products, Inc

McMILLIAN, Circuit Judge.

Performance Products, Inc. (Performance) appeals from a final judgment entered in the District Court 1 for the Eastern District of Missouri condemning as adulterated and seizing certain quantities of an animal drug called Equidantin and other materials used in its manufacture. For reversal Performance argues that Equidantin is not a “new animal drug” within the meaning of 21 U.S.C.’ § 321(w), and thus not subject to premarketing clearance by the Food and Drug Administration (FDA) under 21 U.S.C. § 360b(b), because (1) Equidantin is generally recognized as safe and…