What is FDA's Orange Book (Approved Drug Products With Therapeutic Equivalence Equations)

 

FDA ORANGE BOOK (Approved Drug Products with Therapeutic Equivalence Evaluations)

 
“The Orange Book" is actually the U.S. Food and Drug Administration's (FDA) official listing of Approved Drug Products with Therapeutic Equivalences.

 

“Orange book” is published by the FDA's Centre for Drug Evaluation and Research (CDER).The List contains therapeutic equivalence evaluations for approved multisource prescription drug products. Generic drug evaluations contained in the list are designed to serve as public education and advice to physicians, pharmacists and state health agencies, and to help promote access to lower priced medicines.

The Orange Book is divided into four parts: Part one includes approved prescription drug products with therapeutic equivalence evaluations. Part two lists approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs. Part three includes drug products administered by the Center for Biologics Evaluation and Research. Part four includes a list of approved products that have never been marketed, are for export only, are intended for military use, have been discontinued from marketing, or have had their approvals withdrawn for reasons other than safety or efficacy.

The therapeutic equivalence evaluations contained in the list refer to the FDA's criteria for approved multi-source prescription drug products. The evaluations are presented in code letters corresponding to the type of evaluation used. An explanation of the code appears in the introduction to the list. The main criteria for the inclusion of a drug product on the list are that the product has received an effective approval that has not been withdrawn for efficacy or safety or efficacy causes. Inclusion of products on the list is independent of any current regulatory action through administrative or judicial means against a drug product.