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UNITED STATES v. GENERIX DRUG CORP.

No. 81-1222.

460 U.S. 453 (1983)

UNITED STATES v. GENERIX DRUG CORP. ET AL.

Supreme Court of United States.

Decided March 22, 1983.

Attorney(s) appearing for the Case

Jerrold J. Ganzfried argued the cause for the United States. With him on the briefs were Solicitor General Lee, Assistant Attorney General Baxter, Deputy Solicitor General Claiborne, John J. Powers III, Nancy C. Garrison, and Jeffrey B. Springer.

Robyn Greene argued the cause and filed a brief for respondents.*

Clark M. Clifford, Robert A. Altman, and Daniel F. O'Keefe, Jr., filed a brief for the Proprietary Association as amicus curiae.

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. In statutory terms, we are required to determine whether the term "drug" as used in the relevant sections of the Federal...

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