Referencing approved drug products in ANDA submissions

In a finalised guidance, the US Food and Drug Administration (FDA) has given generic drug developers further information about how to identify reference listed drugs (RLD), reference standards and abbreviated new drug application (ANDA) submissions.

To obtain approval for a generic drug, an ANDA applicant is not required to provide independent evidence of the safety and effectiveness of the proposed drug. The applicant relies on the FDA’s findings from a previously approved drug product (RLD) which has been previously demonstrated to be safe and effective. The applicant must therefore demonstrate that the proposed generic drug is the same as the RLD using specific criteria such as reference standards.

A variety of factors has led to confusion among stakeholders about the difference between what these terms mean and how an ANDA applicant should use them. Factors contributing to the confusion include the fact that many approved drug products have been discontinued, as well as how reference standards have been identified in the Orange Book.

The guidance is intended to clarify what each of these terms means and provides concise recommendations on how to use them in applications. It also clarifies that when an applicant wishes to have a different listed drug designated as an RLD, a request may be submitted by “controlled correspondence”, rather than a “citizen petition”.

Click here to view the full guidance.