What does the Orange Book indicate about drug formulations?

The Orange Book, formally known as the "Approved Drug Products with Therapeutic Equivalence Evaluations," primarily indicates therapeutic equivalency among drug formulations. Therapeutic equivalency is classified using a system that designates products as therapeutically equivalent if they contain the same active ingredients, dosage forms, and strengths, and are expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

The Orange Book helps pharmacists and prescribers identify which generic drugs are interchangeable with brand-name medications based on their equivalence. This promotes the use of generic alternatives, aiding in cost savings while maintaining clinical efficacy for patients. The criteria for therapeutic equivalence also include considerations of pharmaceutical equivalence—products that contain the same inactive ingredients and meet the same standards for quality—but the primary purpose is to establish that various formulations are therapeutically similar.

While the Orange Book also includes information about the approval status of drug products and their market availability, the pivotal role is in assessing and designating therapeutic equivalency, thus providing essential information for medication management and substitution practices in pharmacy.