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UNITED STATES v. GENERIX DRUG CORP.

Nos. 80-5652, 80-5856 and 80-5857.

654 F.2d 1114 (1981)

UNITED STATES of America, Plaintiff-Appellee, v. GENERIX DRUG CORPORATION, a corporation, Lewis Michael Orlove, Gary R. Dubin, and Ofelia Perez, Individual, Defendants-Appellants.

United States Court of Appeals, Fifth Circuit. Unit B

September 4, 1981.

Attorney(s) appearing for the Case

Greene & Cooper, Robyn Greene, Miami, Fla., for defendants-appellants.

Nancy C. Garrison, John J. Powers, III, Washington, D.C., for plaintiff-appellee.

Before MARKEY, Chief Judge, and HILL and THOMAS A. CLARK, Circuit Judges.

JAMES C. HILL, Circuit Judge:

Before a "new drug" may be introduced into interstate commerce it must be approved by the Food and Drug Administration's "new drug application" (NDA) process. 21 U.S.C. § 355(a). Only drugs that are "new drugs" under 21 U.S.C. § 321(p) require an NDA as a condition of marketing. The NDA process is often expensive and time consuming. In the district court, 498 F.Supp...

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