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JOHN D. COPANOS AND SONS, INC. v. F.D.A.

No. 87-1464.

854 F.2d 510 (1988)

JOHN D. COPANOS AND SONS, INC. and Kanasco, Ltd., Petitioners, v. FOOD AND DRUG ADMINISTRATION and Frank E. Young, M.D., Ph.D., Commissioner of Food and Drugs, Respondents.

United States Court of Appeals, District of Columbia Circuit.

Decided August 19, 1988.

Attorney(s) appearing for the Case

James R. Phelps, with whom Robert A. Dormer, Washington, D.C., was on the brief, for petitioners. Judith R. Brunton, Washington, D.C., also entered an appearance for petitioners.

Gerald C. Kell, Atty., Dept. of Justice, with whom John R. Bolton, Asst. Atty. Gen., John R. Fleder, Director, Office of Consumer Litigation, Washington, D.C., Thomas Scarlett, Chief Counsel, Food and Drug Admin. and Eric M. Blumberg, Associate Chief Counsel, Food and Drug Admin., Rockville, Md., were on the brief, for respondents. Richard K. Willard, Asst. Atty. Gen*, Washington, D.C., also entered an appearance for respondents.

Before MIKVA, BUCKLEY and D.H. GINSBURG, Circuit Judges.

Opinion for the Court filed by Circuit Judge D.H. GINSBURG.

D.H. GINSBURG, Circuit Judge:

John D. Copanos & Sons, Inc., and Kanasco, Ltd., affiliated enterprises owned by John D. Copanos (hereinafter referred to collectively as Kanasco), manufacture and distribute human and veterinary drugs, including, until recently, a number of sterile injectable products. These injectable drugs were produced pursuant to a number of New Drug Applications (NDAs) and New...

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