U.S. v. 225 CARTONS, MORE OR LESS OF AN ARTICLE

No. 88-5481.

871 F.2d 409 (1989)

UNITED STATES of America v. 225 CARTONS, MORE OR LESS, OF AN ARTICLE OR DRUG, Each Carton Containing 12/100 Capsule Bottles Labeled in part: (carton) "* * * Sandoz Pharmaceuticals East Hanover NJ 07936 * * *" With an Area Cut Out Showing Bottle Labeling Described Below: (bottle) "* * * Fiorinal With Codeine No. 1 * * * Sandoz, Inc. East Hanover, N.J. * * *" (insert attached to bottle) "Fiorinal With Codeine Capsule * * *." 144 Packages, More Or Less, of An Article of Drug, Each Package Containing 12/100 Capsule Bottles and Covered by an Unlabeled, See-Through Cellophane Overwrap, Labeled in Part: (bottle) "* * * Fiorinal With Codeine No. 2 * * * Sandoz Inc. East Hanover, N.J. * * *" (insert attached to bottle) "Fiorinal With Codeine Capsules * * *" 4,780 Blister Packs, More Or Less, of an Article of Drug, Each Blister Pack Containing 20 Capsules and One Insert, Labeled in Part: (blister pack) and Undetermined Quantities of The Drug, Fiorinal With Codeine No. 1 and Fiorinal With Codeine No. 2, Packaged And Labeled as Described Above. Appeal of SANDOZ PHARMACEUTICALS CORPORATION ("Sandoz").

United States Court of Appeals, Third Circuit.

Decided March 27, 1989.


Attorney(s) appearing for the Case

Peter O. Safir (argued), Bonnie A. Beavers, Kleinfeld, Kaplan & Becker, Washington, D.C., for appellant.

Samuel A. Alito, Jr., U.S. Atty., Jerome L. Merin, Deputy Chief, Civil Div., Newark, N.J., Eric M. Blumberg (argued), Associate Chief Counsel, Food and Drug Admin. (Thomas Scarlett, Chief Counsel, Jeffrey B. Springer, Deputy Chief Counsel, Food and Drug Admin., of counsel), Rockville, Md., for appellee.

Before SLOVITER and BECKER, Circuit Judges, and POLLAK, District Judge.


OPINION OF THE COURT

SLOVITER, Circuit Judge.

Appellant Sandoz Pharmaceuticals Corporation has been unsuccessful in its attempt to obtain Food and Drug Administration (FDA) approval of its new drug applications for the products in question under the usual premarket clearance procedures required by 21 U.S.C. § 355(a) & (b). Its contention that the products can nonetheless be distributed in commerce rests on its claim that they are "generally recognized...

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