United States v. Generix Drug Corp.

The question presented is whether the statutory prohibition against the marketing of a “new drug” without the prior approval of the Food and Drug Administration (FDA) requires respondent Generix Drug Corp. to have approved new drug applications (NDA’s) before it may market its generic drug products. In statutory terms, we are required to determine whether the term “drug” as used in the relevant sections of the Federal Food, Drug, and Cosmetic Act (Act), as amended, 21 U. S. C. §301 et seq. (1976 ed. and Supp V), refers only to the active ingredient in a drug product or to the entire product.…