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Not a Generic? Must Be a 505(b)(2)?

Generic or 505(b)(2)?

The Office of Generic Drugs (OGD) receives many applications under 505(j) that do not meet the statutory definition of a generic drug. The applications reference an approved drug (the referenced listed drug) but differences in formulation, labeling, or other factors cause OGD to recommend that the application be submitted under 505(b)(2). OGD apparently found the need to consolidate all of the allowed and unallowed changes in a newly released guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application. Generic or 505(b)(2)?

Those companies working in 505(b)(2) drug development are not likely to benefit from this guidance – you already know you are purposefully not developing a generic. In fact, this guidance incorporates of those types of 505(b)(2) that reference a listed drug (LD) – and there is no discussion of multiple LD’s or how to reference them.  Of course, there are many 505(b)(2) projects that do not rely on a LD – 505(b)(2)’s can be NCE’s, they can originate ex-US, etc.

Since the intent of the guidance is to describe the situations where the application is not a 505(j), it doesn’t fully address combination products and other situations where the product could actually be a 505(b)(1) and not a 505(b)(2).  For those situations, contact Camargo, your expert in 505(b)(2) drug development.


Author: Ken Phelps, President and Chief Executive Officer, Camargo Pharmaceutical Services