United States v. Superharm Corporation

530 F.Supp. 408 (1981)

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Nature of the Case

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Facts

P contends that Superpharm Corporation D, and Norman E. Rubin, president of Superpharm, engaged in the manufacture and distribution of a human drug, furosemide, in the absence of approval by the Food and Drug Administration ('FDA'). Ds are alleged to be violating drug approval provisions that prohibit the marketing of 'new drugs,' 21 U.S.C. § 321(p), in interstate commerce without FDA approval. The court issued a restraining order prohibiting the further manufacture or sale of this drug unless and until approval is obtained from the FDA. Settlement discussions ensued, and numerous issues were resolved, but the parties have been unable to settle whether this court has the authority to order the recall of drug products improperly marketed in interstate commerce.