United States v. 225 Cartons, More or Less, of an Article or Drug

OPINION OF THE COURT

SLOVITER, Circuit Judge.

Appellant Sandoz Pharmaceuticals Corporation has been unsuccessful in its attempt to obtain Food and Drug Administration (FDA) approval of its new drug applications for the products in question under the usual premarket clearance procedures required by 21 U.S.C. § 355(a) & (b). Its contention that the products can nonetheless be distributed in commerce rests on its claim that they are “generally recognized” to be safe and effective, a claim the district court rejected. The issue presented on appeal requires this court to interpret for the first time…