FDA Offers First Major Update to ‘Orange Book’ Website

Regulatory NewsRegulatory News
| 15 August 2016 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.”

FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another, while FDA's Purple Book is list of all licensed biologics and biosimilars (the biological equivalent of the pharmaceutical Orange Book).

This major revision of the Orange Book, known formally as the Approved Drug Products with Therapeutic Equivalence Evaluations and which first appeared as a published list in 1980 and came online in 1997, is a first for the web site and features an updated design with more user-friendly search options.

Users can search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number. Groups of “accordion” panels also can be opened to reveal new features and contact information.

The updated Orange Book website is the latest in a series of FDA efforts to improve the agency’s online presence. FDA released its 33rd edition of the Orange Book in 2013.

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)


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