Generic Drugs and the Generic Industry

Generic drugs are made with the same active ingredient and are therapeutically equivalent to the brand name drug, usually at a fraction of the cost. This chapter aims to familiarize the reader with the generic drug approval process and the quality attributes associated with generic drug products. Since the early part of the last century, new drugs have been approved by the submission of a new drug application before it can be commercially sold in the United States. The Food and Drug Administration (FDA) classifies generic drugs as therapeutically equivalent to branded drug products if they are safe and effective, pharmaceutically equivalent, and bioequivalent to the branded reference drug product, adequately labeled and manufactured in compliance with Current Good Manufacturing Practice regulations. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the branded reference listed drug.