FDA publishes guidance for industry on ANDA submissions

The US Food and Drug Administration yesterday, published the guidance for industry entitled “ Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions.”

This guidance finalizes the draft guidance issued in January 2017, and provides information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA. The guidance is intended to clarify what these terms mean and how to accurately use these terms in an ANDA.

The guidance also clarifies references to approved drug products that appear on the “Discontinued Drug Product List” and FDA’s identification of certain reference standards as RLDs in the printed and electronic version of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). This guidance will be of interest to the holders of pending or approved ANDAs and future ANDA applicants. The FDA anticipates that this guidance will help applicants understand the meaning of terms related to ANDA submissions and help them identify the previously approved product(s) that needs to be referenced in an ANDA submission, thereby facilitating the submission and review of ANDAs.