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USFDA's Draft Guidance: Orange Book Questions and Answers

Updated: Jul 24, 2022

On 22-July 2022, USFDA released multiple guidance among them one is "Orange Book Questions and Answers Guidance for Industry.


What is ORANGE BOOK?

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

Orange book Database can be found here: LINK

This guidance is intended to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book.


The guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book and covers topics such as the content and format of the Orange Book, petitioned abbreviated new drug applications (ANDAs), the movement of drug products between the Active and Discontinued sections in the Orange Book, and drug product and patent listings.


The Orange Book is composed of four main parts:

(1) The Prescription Drug Product List

(2) The OTC Drug Product List

(3) The Drug Products

(4) The Discontinued Drug Product List


The Orange Book contains additional information, including three appendices and two addenda related to patents and exclusivity. The Orange Book website also has a number of additional resources that can assist stakeholders with using the Orange Book and related questions.


CLICK this LINK to know the Questions and Answers related to Orange Book.

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