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EDISON PHARMACEUTICAL v. FOOD & DRUG ADMINISTRATION

No. 77-1636.

600 F.2d 831 (1979)

EDISON PHARMACEUTICAL CO., INC., Petitioner, v. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, and Joseph A. Califano, Secretary, Department of Health, Education, and Welfare, Respondents.

United States Court of Appeals, District of Columbia Circuit.

Decided March 21, 1979.

Attorney(s) appearing for the Case

Howard F. Cerny, New York City, for petitioner.

Margaret A. Cotter, Atty., Dept. of Justice, and Donald O. Beers, Asst. Chief Counsel, Food and Drug Administration, Rockville, Md., with whom Charles R. McConachie and James A. Calderwood, Attys., Dept. of Justice, and Richard M. Cooper, Chief Counsel, and Jeffrey B. Springer, Deputy Chief Counsel, Food and Drug Administration, Washington, D.C., were on the brief, for respondents.

Before J. EDWARD LUMBARD, Senior Circuit Judge for the Second Circuit, and TAMM and LEVENTHAL, Circuit Judges.

Opinion for the court filed by TAMM, Circuit Judge.

TAMM, Circuit Judge:

Petitioner, Edison Pharmaceutical Co., Inc. (Edison) seeks to set aside a final order1 of the Commissioner of Food and Drugs (Commissioner) refusing approval of its new drug application (NDA) for the drug Cothyrobal.2 Edison contends that the Commissioner's order is not supported by substantial evidence and that the Food and Drug...

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