The Approved Drug Products with Therapeutic Equivalence Evaluations aka the “Ora

The Approved Drug Products with Therapeutic Equivalence Evaluations aka the “Orange Book” is published by the FDA under Section 505 of the Federal Food, Drug, and Cosmetic Act. This free resource can be broken down into 4 parts: approved prescription drug products with therapeutic equivalence evaluations, approved OTC drug products that may not be marketed without new drug applications or ANDAs, drug products administered by the Center for Biologics Evaluation and Research and discontinued products. A new edition of the Orange Book is published each year, which is supplemented by monthly updates; however, an Electronic Orange Book (EOB) also exists that is updated daily. The daily refresh is intended to ensure users have access to the most up-to-date drug information. The EOB includes: new drug applications, all product changes, patent and exclusivity details. The information is most readily available by performing a search in the following link: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. Users may search by active ingredient, proprietary name, applicant, or application number. If a printed version is preferred, a hardcopy may be requested from the Government Printing Office or downloaded in full as a PDF version.
The Orange Book serves as a timesaving, informative tool for
healthcare professionals. The electronic accessibility (either via the web or over a mobile app) provides instant answers to questions that would otherwise require a phone call to FDA representatives. Since generics are often cost effective for consumers, their availability/viability are important points of considerations for pharmacists and providers. This is where the EOB truly shines; users can search for any FDA approved product by Proprietary Name and then under the “TE” (therapeutic equivalent) Code column, see a list of any active generic drugs available. If the column is blank and the healthcare professional wants to have an idea of when a generic may become available, he/she can refer to the patent and exclusivity expiration dates. Thus, within seconds, the EOB empowers healthcare providers to make informed decisions as to which drug or its generic equivalent best suits their patient.
With an overwhelming number of drugs available on the market, clear and distinct groupings of similar agents is essential for proper prescription application and use. The EOB is an adequate resource that achieves this goal and is particularly effective when accessed electronically as the information is updated daily. This ensures the user performing the drug search is receiving the most accurate/timely information available at time of initiation.
U.S. Food and Drug Administration. (2020). Orange Book Preface. FDA. https://www.fda.gov/drugs/development-
approval-process-drugs/orange-book-preface
U.S. Food and Drug Administration. (2020, November 30). Orange Book 101: An Overview of FDA’s

The Approved Drug Products with Therapeutic Equivalence Evaluations aka the “Ora
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