United States v. Generix Drug Corp.
United States Supreme Court
460 U.S. 453 (1983)

- Written by Alex Ruskell, JD
Facts
The Food and Drug Administration required Generix Drug Corp. (defendant) to have approved new-drug applications before it could market its generic drugs. Generix argued that its generic drugs were not new drugs under the Food, Drug, and Cosmetic Act because “drug” only referred to the active ingredient and not the product as a whole. Thus, if a pioneer drug with the active ingredient had already received approval, a generic drug with that same active ingredient should not be required to go through the same process because it was not in fact a new drug.
Rule of Law
Issue
Holding and Reasoning (Stevens, J.)
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