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HYNSON, WESTCOTT AND DUNNING, INC. v. RICHARDSON

No. 71-1717.

461 F.2d 215 (1972)

HYNSON, WESTCOTT AND DUNNING, INCORPORATED, Petitioner, v. Elliot RICHARDSON, Secretary of Health, Education and Welfare and Charles C. Edwards, Commissioner of Food and Drugs, Respondents.

United States Court of Appeals, Fourth Circuit.

Decided May 24, 1972.

Attorney(s) appearing for the Case

Edward Brown Williams, Washington, D. C. (Jan Edward Williams and Harter, Calhoun & Williams, Washington, D. C., Robert H. Patterson, Jr., and McGuire, Woods & Battle, Richmond, Va., and John Kyle Worley on brief), for petitioner.

Gregory B. Hovendon, Atty., Dept. of Justice (Richard W. McLaren, Asst. Atty. Gen., and Peter Barton Hutt, Asst. Gen. Counsel, Food, Drugs and Environmental Health Division, Eugene M. Pfeifer, Atty., U. S. Dept. of Health, Education, and Welfare, on brief), for respondents.

Joel E. Hoffman, Washington, D. C. (Robert L. Wald, Selma M. Levine, and Wald, Harkrader & Ross, Washington, D. C., on brief), for amicus curiae.

Before BUTZNER, RUSSELL and FIELD, Circuit Judges.

DONALD RUSSELL, Circuit Judge:

The appellant, a drug manufacturer, seeks review of a final order withdrawing marketing approval (NDA) of the drug Lutrexin by the Commissioner of Food and Drugs, Department of Health, Education and Welfare.1 The appellant alleges error in such order of withdrawal (1) for failure to sustain its claim of exemption from withdrawal on account of lack of "substantial evidence" of effectiveness of its drug and...

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