From Our Perspective: The Orange Book at 40: A valued FDA resource continually enhanced by user input
October 31, 2020, marks the 40th anniversary of the first official publication of the U.S. Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. One of FDA’s most-used resources, the Orange Book lists approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information. The evaluations it contains serve as public information and advice to state health agencies, prescribers, health care providers, and pharmacists. This useful information helps Orange Book users educate patients on drug selection and can help keep health care costs down for patients.
The Orange Book is the only official source for therapeutic equivalence evaluations and reference listed drug (RLD) data for FDA-approved generic and brand-name drugs.
FDA evaluates approved multiple-source drugs for therapeutic equivalence and assigns a rating code which appears in the Orange Book. The therapeutic equivalence code ratings identify approved drugs that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered under the conditions specified in the labeling. These ratings serve as a guide for generic substitution among drugs.
The Orange Book is particularly critical to determining when a pharmacist can substitute a generic drug for the brand-name drug. According to the Association for Accessible Medicines, 90% of all prescriptions dispensed in the United States in 2019 were filled with a generic drug.
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