The Orange Book is the common name for the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations”. This reference work contains lists of drug products approved by the FDA, and its purpose is to enable providers and patients find substitute drugs that are therapeutically equivalent to a name brand drug. The lists include both approved prescription and OTC drugs and biologics. There is a separate list of approved products that are not on the market which the agency has determined were not withdrawn due to safety or efficacy reasons. An addendum lists patent and exclusivity information for the products on the main lists. The agency updates the publication regularly, and the current version is the 38thedition.
The Orange Book is pretty sizeable (the PDF version runs close to 11 MB), and the files are updated on a monthly basis. You can search the database online through its website, or through the free Orange Book Express 2.0 app. The app is available for iOS and Android devices – just click the link on the Orange Book website to download the app from the appropriate store. This reference work is pretty useful if you are a patient with a prescription, since it’s pretty common for the major pharmacies to switch to a different therapeutic equivalent based on price or availability, and the app enables you to quickly find reliable data on your current or new product. Therapeutically equivalent products must be the same drug form with the same active ingredient, but they don’t have to include the same excipients (the supporting materials used to create the final dose form), and it’s not unusual for different drug products to produce slightly different effects in a single patient. Arm yourself with accurate information so you and your doctor can make the best choices for your personal health outcome.
Text Copyright © 2018 Katrina Rogers