Implications of the Lannett and Pharmadyne decisions.

The Lannett (United States v. Articles of Drug) and Pharmadyne (Pharmadyne Laboratories, Inc. v. Kennedy) court decisions are explained and their implications regarding premarket approval of drugs are discussed. The Lannett decision has led to confusion over whether FDA premarketing approval is required for products containing drugs recognized as safe and effective. The Lannett decision has no binding legal effect. Premarketing clearance must be obtained by all drug manufacturers, including the producers of generics.