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USV PHARMACEUTICAL CORP. v. WEINBERGER

No. 72-666.

412 U.S. 655 (1973)

USV PHARMACEUTICAL 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

Joel E. Hoffman argued the cause for petitioner. With him on the briefs were Robert L. Wald, Selma M. Levine, Philip Elman, and Philip J. Franks.

Deputy Solicitor General Friedman and Andrew L. Frey argued the cause for respondents. With Mr. Frey on the briefs were Solicitor General Griswold, Assistant Attorney General Kauper, Deputy Solicitor General Wallace, Howard E. Shapiro, 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.

Thomas D. Finney. Jr., Thomas Richard Spradlin, and Daniel F. O'Keefe, Jr., filed a brief for the Proprietary Assn. as amicus curiae.

MR. JUSTICE DOUGLAS delivered the opinion of the Court.

Petitioner sells a line of drugs containing, as a principal active ingredient, citrus bioflavonoid, which is an extract from fruit skins. The drugs are sold in capsules, syrup, and tablets. In the 1950's new drug applications (NDA's) were filed and became effective for seven of them; two, however, were sold without any NDA. In 1961 the Food and Drug Administration (FDA...

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