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COOPER LABORATORIES, INC. v. COMMISSIONER, FED. F. D. A.

No. 72-1866.

501 F.2d 772 (1974)

COOPER LABORATORIES, INC., Petitioner, v. COMMISSIONER, FEDERAL FOOD AND DRUG ADMINISTRATION, Respondent.

United States Court of Appeals, District of Columbia Circuit.

Decided April 19, 1974.

Rehearing Denied June 26, 1974.

Attorney(s) appearing for the Case

William R. Pendergast, Washington, D.C., for petitioner.

Howard S. Epstein, Atty., Dept. of Justice, with whom Peter Barton Hutt, Asst. Gen. Counsel, Food, Drugs and Product Safety Division, Food and Drug Administration, Joanne S. Sisk, Chief, Appellate and Special Proceedings Branch, Food and Drug Administration, and Jay H. Geller, Atty., Dept. of Health, Education and Welfare, were on the brief, for respondent.

Before WRIGHT and LEVENTHAL, Circuit Judges, and MATTHEWS, Senior District Judge.

J. SKELLY WRIGHT, Circuit Judge:

To be marketed in interstate commerce under the Food, Drug and Cosmetic Act, a drug must generally be covered by a "new drug application" (NDA) approved by the Food and Drug Administration (FDA).1 In 1944 the FDA approved an NDA for Protamide, an injectible colloidal solution of denatured proteolytic enzyme, upon a finding that the drug was safe for human use,...

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