Premo Pharmaceutical Laboratories

Premo Pharmaceutical Laboratories was a prominent American generic drug manufacturer based in South Hackensack, New Jersey, that operated during the mid-20th century. The company is historically significant for its extensive legal challenges against the U.S. Food and Drug Administration (FDA) regarding the regulatory requirements for generic medications. These legal battles, particularly those concerning the definition of a "new drug," were instrumental in the eventual creation of the 1984 Hatch-Waxman Act. Premo specialized in the production of generic small molecule therapeutics, including versions of popular antibiotics and corticosteroids. Following years of regulatory and legal scrutiny, the company was acquired by the Lemmon Company in 1981, which was later integrated into Teva Pharmaceutical Industries.