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PREMO PHARMACEUTICAL LABORATORIES, INC. v. U. S.

No. 78 Civ. 5435(MP).

475 F.Supp. 52 (1979)

PREMO PHARMACEUTICAL LABORATORIES, INC., Plaintiff, v. UNITED STATES of America, Joseph A. Califano, Jr., Secretary of Health, Education and Welfare, and Donald M. Kennedy, Commissioner of Food and Drugs, Defendants.

United States District Court, S. D. New York.

July 27, 1979.

Attorney(s) appearing for the Case

Kirschstein, Kirschstein, Ottinger & Cobrin by David B. Kirschstein, New York City, Keller & Heckman by John S. Eldred and Deborah Shur Trinker, Washington, D. C., for plaintiff.

Robert B. Fiske, U. S. Atty., S.D.N.Y., by Janis Farrell and John M. O'Connor, Asst. U. S. Attys., New York City, for U. S. and H. E. W.

Jacqueline H. Eagle, Rockville, Md., for Food and Drug Administration.

OPINION

POLLACK, District Judge.

This is a suit by a manufacturer of pharmaceutical drugs against the Secretary of Health, Education and Welfare and the Commissioner of Food and Drugs, seeking a declaratory judgment that a questioned product manufactured by the plaintiff is not classifiable as a new drug and therefore may be freely sold and distributed without prior approval by the Food and Drug Administration ("FDA" hereafter). The FDA has initiated...

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