FDA releases guidance for choosing ANDA or 505(b)(2) route for drug approval

Last week the FDA released a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application” to help companies choose between those two routes for the approval of a proposed drug that contains an already-approved active ingredient. You can download the guidance directly from here.

After reading through the guidance, I came to the conclusion that the major difference between ANDAs and 505(b)(2) applications can be found where it states:

The types of studies that may be submitted in a 505(b)(2) NDA may include clinical investigations to establish the safety and/or effectiveness of a product. Generally, ANDA applicants also have significant flexibility in the types of studies, data, and information they may submit in an ANDA to support the requirements for ANDA approval, so long as clinical investigations are not submitted to establish the safety or effectiveness of a product. Page 7, Section B, Subsection 1. (emphasis added)

So there you have it in a nutshell. Need studies to establish safety and/or effectiveness of your proposed product? Then 505(b)(2) is your route. Otherwise, the ANDA route would be your easiest and most direct way to obtain approval.

There is, however, one minor advantage that a 505(b)(2) application may have over an ANDA. The situation occurs when the NDA holder has requested the FDA to delist a patent, but the patent remains in the Orange Book and is tagged by the FDA as being the subject of a delisting request. In such cases, an ANDA applicant must provide a certification for the patent, but a 505(b)(2) applicant does not.

It may seem unlikely that a patent owner would file suit in response to a Paragraph IV certification from an ANDA applicant for a patent that the NDA holder wants to delist. However, there may be situations where it would be advantageous to assure that the patent reckoning would not occur until after the proposed drug is approved. Filing a 505(b)(2) would do that in most circumstances since the patent owner would not know of the filing until after approval.


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