Audio Transcript

A 505(b)(2) application is an application for which you relied upon information which you do not own or have right of reference to, including published literature.

In this context, 505(b)(2) applications are often submitted as changes to already approved products. These products can also be submitted as 505(b)(2) for changes in dosage, dosage form, formulation, strength, route of administration, dosing regimen, indication, and/or active ingredients, such as different salt. It is important to note that if you have a different salt than one that is already marketed, it cannot be submitted as a generic product. It must be submitted through the 505(b)(2) new drug application route.

If you substitute an unapproved active ingredient for another ingredient, then the product has to be submitted for approval using the NDA process. In addition, the combination of two previously approved products into a single product must also be submitted through the NDA process.

What is unique about a 505(b)(2) submission? You can use this pathway to rely on general information such as non-product specific published literature. In this application, you can also rely upon FDA's previous finding of safety and effectiveness for a previously approved product. If you choose to rely on something that we have already approved, you have to submit a scientific bridge to an already approved product. Generally this is done by submitting data showing your product's bioequivalence or bioavailability to the already approved product. It also requires patent certifications and statements---details of which can be found in the Resources tab of this module.