FDA Makes Critical Data Update to the Orange Book

On Wednesday, January 25^th, the FDA unveiled a critical data update to Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the “Orange Book.”  According to the Agency’s announcement, “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.”

These modifications were made to reflect the FDA’s recently published draft guidance entitled “Referencing Approved Drug Products in ANDA Submissions.”  FDA states that the print edition of the Orange Book has been updated to reflect these changes, and updates will be made to the mobile app in the near future.

Furthermore, the FDA states that the “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.”

For additional information, view the FDA’s press release, or refer to the Agency’s pre-recorded webinar.

Are you in the process of developing a generic drug? Do you need help developing an ANDA or other FDA submission? We can help.  To learn more about our services, contact us today.

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