ABSTRACT
Before enactment of the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act), Abbreviated New Drug Applications (ANDAs) were permitted for duplicate versions of drug products, though only for drugs first approved by the U.S. Food and Drug Administration (FDA) between 1938 and 1962. Generally, such drugs were subject to the Drug Efficacy Study Implementation (DESI) program andwere determined to be both safe and effective or were otherwise removed
from the market. Products were eligible candidates for ANDAs if they were the same as an already approved drug in terms of dosage form, route of administration, strength, active ingredient, indication(s), and other conditions for using the drug product. Certain drug products were required to demonstrate bioequivalence if they were determined by FDA to have an actual or potential bioavailability problem and if appropriate methodology and standards were available to conduct such testing.
