What is the purpose of the Orange Book published by the FDA?

The purpose of the Orange Book published by the FDA is to serve as a comprehensive reference for approved drug products that includes evaluations of their therapeutic equivalence. This resource is essential for healthcare professionals, pharmacists, and patients to understand which generic drugs and brand-name drugs are considered therapeutically equivalent, meaning they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

The Orange Book is instrumental in the approval process for generic drugs, as it provides a list of those that are interchangeable with their brand-name counterparts. This helps to facilitate access to safe and effective medications while promoting affordability and competition within the pharmaceutical market.

Understanding this significance underscores the importance of the Orange Book in drug therapy and regulatory affairs, as it directly impacts prescribing practices and patient access to medications.