FDA introduces reference standard data updates to the Orange Book

On January 25, 2017, the FDA introduced an important data update to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book.” Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA made these modifications to reflect recent clarifications published in the draft guidance for industry “Referencing Approved Drug Products in ANDA Submissions.” The print edition of the Orange Book also reflects these updates. The Orange Book mobile app will be updated to reflect these changes in the near future.

These updates will help applicants submitting an abbreviated new drug application (ANDA) to seek approval of a generic drug to identify:

• an RLD, i.e., a previously approved drug product for which an applicant may seek approval of a generic drug;
• a reference standard, i.e., the previously approved drug selected by FDA that an applicant must use in the conduct of in vivo bioequivalence studies required for approval of an ANDA; and
• the basis of submission for the ANDA.

Further information is available in the pre-recorded webinar, “Referencing Approved Drug Products in ANDA Submissions.”