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CIBA CORP. v. WEINBERGER

No. 72-528.

412 U.S. 640 (1973)

CIBA CORP. v. WEINBERGER, SECRETARY OF HEALTH, EDUCATION, AND WELFARE, ET AL.

Supreme Court of United States.

Decided June 18, 1973.

Attorney(s) appearing for the Case

Clyde A. Szuch argued the cause and filed a brief for petitioner.

Deputy Solicitor General Friedman argued the cause for respondents. On the brief were Solicitor General Griswold, Assistant Attorney General Kauper, Andrew L. Frey, Howard E. Shapiro, George Edelstein, and Peter Barton Hutt.*

Bruce J. Terris, Joseph Onek, and Peter H. Schuck filed a brief for American Public Health Assn. et al. as amici curiae urging affirmance.

MR. JUSTICE DOUGLAS delivered the opinion of the Court.

Petitioner manufactures a drug called Ritonic Capsules† for which it filed a new drug application (NDA) that became effective in 1959. Under the Act then in force, an NDA for a "new drug" required the manufacturer to submit to the Food and Drug Administration (FDA) adequate proof of the drug's safety. This particular NDA became effective...

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