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EDISON PHARMACEUTICAL CO., INC. v. FOOD & DRUG ADMIN.

No. 73-2254.

513 F.2d 1063 (1975)

EDISON PHARMACEUTICAL COMPANY, INC., Petitioner, v. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, and Caspar W. Weinberger, Secretary, Department of Health, Education and Welfare, Respondents.

United States Court of Appeals, District of Columbia Circuit.

Rehearing Denied August 11, 1975.

Attorney(s) appearing for the Case

Howard Franklin Cerny, Washington, D. C., for petitioner.

Margaret A. Cotter, Atty., Dept. of Justice, with whom Thomas E. Kauper, Asst. Atty. Gen., Dept. of Justice, Alvin L. Gartlieb, Deputy Asst. Gen. Counsel, Joanne S. Sisk and Barbara Lewis Spivak, Attys., Dept. of Health, Education and Welfare, were on the brief, for respondents.

Before WILKEY, Circuit Judge, NICHOLS, Judge, United States Court of Claims, and GASCH, United States District Court Judge for the District of Columbia.

Rehearing En Banc Denied August 11, 1975. See 517 F.2d 164.

Opinion for the Court filed by District Judge GASCH.

GASCH, District Judge.

This is an appeal from a final order1 of the Commissioner of Food and Drugs (Commissioner) that the new drug application (NDA) for Cothyrobal (NDA 16-865) submitted by petitioner Edison Pharmaceutical Company...

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