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Hoffmann-LaRoche, Inc. v. Weinberger

425 F. Supp. 890 (1975)

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Hoffmann-LaRoche, Inc. v. Weinberger

United States District Court for the District of Columbia
425 F. Supp. 890 (1975)

AR

Facts

The Food and Drug Administration (FDA) had a policy for “me-too drugs” that allowed the sale of me-too drugs without the approval of a full new-drug application (NDA). Me-too drugs were chemically equivalent to pioneer drugs that had already received approved NDAs, and the FDA believed a full NDA for me-too drugs was unnecessary because of the FDA’s limited compliance resources and because the need to police such drugs was minimal. Hoffmann-LaRoche, Inc. (plaintiff) sued, arguing it had to wait for full NDA approval to market its drug but another manufacturer who made a me-too version of the drug only had to file an abbreviated NDA.

Rule of Law

Issue

Holding and Reasoning (Green, J.)

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Casebooks

Food and Drug Law

Key Terms