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NORWICH EATON PHARMACEUTICALS, INC. v. BOWEN

No. 86-3397.

808 F.2d 486 (1987)

NORWICH EATON PHARMACEUTICALS, INC., Plaintiff-Appellee, v. Otis R. BOWEN, Secretary of Health and Human Services; Frank E. Young, M.D., Ph.D., Commissioner of Food and Drugs; United States Food and Drug Administration, Defendants-Appellants.

United States Court of Appeals, Sixth Circuit.

Decided January 9, 1987.

Attorney(s) appearing for the Case

Gerald F. Kaminski, Asst. U.S. Atty., Cincinnati, Ohio, Kenneth L. Jost, Dept. of Justice, Washington, D.C., Mark A. Heller, Assoc. Chief Counsel for Enforcement, Rockville, Md., Robert S. Greenspan, Richard A. Olderman argued, Appellate Staff, Dept. of Justice, Washington, D.C., for defendants-appellants.

Jonathan M. Norman, Cincinnati, Ohio, for amicus curiae Lymphomed, Inc.

Frank C. Woodside, III argued, Cincinnati, Ohio, Linda E. Roesch, Thomas O. Henteleff, Alan H. Kaplan, Peter R. Mathers, Washington, D.C., for plaintiff-appellee.

Before KENNEDY and NORRIS, Circuit Judges, and CONTIE, Senior Circuit Judge.

KENNEDY, Circuit Judge.

Defendants-appellants Otis R. Bowen, Secretary of Health and Human Services, et al. ("the Government") appeal from a judgment for plaintiff-appellee Norwich Eaton Pharmaceuticals, Inc. ("Norwich") in an action seeking a declaration of rights under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392 ("FFDCA"). The Government argues that the District Court exceeded the appropriate scope of review and that the District...

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