United States v. Generix Drug Corporation, a Corporation, Lewis Michael Orlove, Gary R. Dubin, and Ofelia Perez, Individual

JAMES C. HILL, Circuit Judge:

Before a “new drug” may be introduced into • interstate commerce it must be approved by the Food and Drug Administration’s “new drug application” (NDA) process. 21 U.S.C. § 355(a). Only drugs that are “new drugs” under 21 U.S.C. § 321(p) require an NDA as a condition of marketing. The NDA process is often expensive and time consuming. In the district court, 498 F.Supp. 288, the plaintiff-appellee, the United States, alleged that Generix was distributing “new drugs” without approved new drug applications. The United States sought to enjoin this distribution…