The List


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Table of Contents

The List


Why does FDA publish the List?

Section 505A(b) directs FDA to:

Experts in Pediatric Research

Development of the List

Development of the List

How many drugs are there in the Orange Book?

How many drugs in the Orange Book have patent or exclusivity protection?

Publication of the List

What is the List?

What is an “approved drug” for purposes of the List?

What is an active moiety?

What does the List look like?

PPT Slide

Introduction to the List

Priority Section of the List

PPT Slide

PPT Slide

How many drugs are on the priority section of the List?

How is the priority section of the list arranged?

Therapeutic Classes

What is the difference between the priority section and the rest of the list?

Being on the List does NOT mean:

How does FDA update the list?

What issues has FDA had to clarify?

What issues related to the List does FDA anticipate taking to AC?


Additional Information

Author: LC