USV Pharmaceutical Corp. v. Weinberger

Petitioner sells a line of drugs containing, as a principal active ingredient, citrus bioflavonoid, which is an extract from fruit skins. The drugs are sold in capsules, syrup, and tablets. In the 1950’s new drug applications (NDA’s) were filed and became effective for seven of them; two, however, were sold without any NDA. In 1961 the Pood and Drug Administration (FDA) advised petitioner that two of the products, when distributed under the existing labels, were not new drugs. These drugs were recommended for a wide variety of ailments from bleeding, to hypertension, to ulcerative colitis.…