Supreme Court of the United States March 22, 1983, 81-1222 (United States v. Generix Drug Corp.)

Justice Stevens

delivered the opinion of the Court.

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.