FDA In Brief: FDA Takes Actions to Enhance Utility of the Orange Book

May 29, 2020

Media Inquiries

The following quote is attributed to Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research:

“Providing timely and accurate information about generic drugs supports the FDA’s priority of facilitating the timely development and approval of these products and fostering competition in the marketplace.

“First published as an official list in 1980, one of the fundamental tools for providing information about generic drugs to the public is the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, more commonly known as the Orange Book.

“In October, we will celebrate the 40th anniversary of the Orange Book, which is one of the most used resources on FDA.gov. Although the Orange Book already provides extensive information about approved drug products, we want to ensure that it provides as much value as possible to those that rely on it, including consumers, health care professionals and drug developers. To this end, we are providing draft guidance and seeking additional feedback from a wide range of stakeholders and the public to help us consider how we may enhance this resource as we pursue the ultimate goal of improving access to high quality, affordable treatment options for Americans.”

Today, the U.S. Food and Drug Administration issued a Federal Register notice to open a docket for submission of public comment on the publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the "Orange Book.” The FDA would like to know how stakeholders and the public use the Orange Book and how it can be improved to make sure the published information is clear and helpful. In addition to general comments, the FDA is interested in learning what types of people or entities use the Orange Book and which sections are most useful to them; if the information regarding therapeutic equivalence is generally useful; and what information or features could be incorporated to increase utility of the Orange Book.
The FDA today also published draft guidance for industry: “Orange Book – Questions and Answers” to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book. The draft guidance provides answers to commonly asked questions the FDA has received from interested parties, including topics such as content and format of the Orange Book; petitioned Abbreviated New Drug Applications; the movement of drug products between the “Active” and “Discontinued” Sections in the Orange Book; and patent listings.
Additionally, the FDA issued a Federal Register notice to solicit comments on listing patent information in the Orange Book. The agency is seeking input on the types of patents currently listed and the potential impact any changes to current patent listing practices may have on drug product development.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.