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Know About FDA Orange Book

The US Food and Drug Administration (FDA or Agency) signaled on January 30 what may be inconsistent with its role in administering a list of approved drugs with therapeutic equivalence ratings (known as the Orange Book).

In the past, the FDA's role in Orange Book has been very ministerial. However, over the next year, the FDA may take a more proactive approach to Orange Book. You may look at Wizmed for consolidated pharma data.

The FDA announced its potential new role as the Orange Book in a press release accompanying the publication of draft guidelines and marketing status notices under Section 506I of the Federal Food, Drugs and Cosmetics Act (Guidelines).

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The guidelines aren't really that great; it largely provides guidance on the content and format of the marketing status report under Section 506I of the Federal Food, Drugs, and Cosmetics Act (FFDCA), a new amendment to the FDA Reauthorization Act 2017.

Under other provisions, the 506I requires sponsors to apply for treatment. FDA: (1) 180 days before an approved drug is withdrawn from sale; and (2) notification within 180 days after the drug is approved if the drug is not available for sale within the same period.

If you fail to provide the required notification, the product can be moved from active to an Orange Book area that is no longer available.