What is the FDA Orange Book?

What is the FDA Orange Book?

• A. Approved Drug Products with Therapeutic Equivalence Evaluations
• B. Therapeutic Equivalence Rating System
• C. Lists all marketed drug products with their therapeutic equivalence
• D. Biologic Product Catalog and Biosimilarity Guide

Answer: (A)

The FDA Orange Book is the official listing of approved drug products with their therapeutic equivalence evaluations. It’s produced by FDA to show whether a brand-name drug and a generic version are considered interchangeable. Each product pairing receives a therapeutic equivalence code; generally, a rating of A indicates the products are therapeutically equivalent and interchangeable, while a B rating signals they are not. Pharmacists use this resource to decide if a generic can be substituted for a prescribed brand-name drug without compromising safety or efficacy. It focuses on small-molecule drugs and their approved formulations, not biologics (which are covered in a separate resource). The title itself—Approved Drug Products with Therapeutic Equivalence Evaluations—matches the essence of what the Orange Book provides.

The FDA Orange Book is the official listing of approved drug products with their therapeutic equivalence evaluations. It’s produced by FDA to show whether a brand-name drug and a generic version are considered interchangeable. Each product pairing receives a therapeutic equivalence code; generally, a rating of A indicates the products are therapeutically equivalent and interchangeable, while a B rating signals they are not. Pharmacists use this resource to decide if a generic can be substituted for a prescribed brand-name drug without compromising safety or efficacy. It focuses on small-molecule drugs and their approved formulations, not biologics (which are covered in a separate resource). The title itself—Approved Drug Products with Therapeutic Equivalence Evaluations—matches the essence of what the Orange Book provides.