Abstract

The 505(b)(2) new drug application (NDA) is a regulatory strategy for filing new NDA relying on some information/data disclosed under other NDA that is 505(b)(1). It is one of three U.S. Food and Drug Administration (FDA) drug approval pathways used by many pharmaceutical companies for filling their NDA’s.  In 1984, this was created by the Hatch-Waxman Amendments, with the term 505(b)(2) referring to a section of the Federal FDA Act. This pathway was created to avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug. Thus, using this pathway product can be approved relying on data not developed by the NDA applicant.

It usually contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, to come from studies not conducted by the applicant for example; safety and efficacy information on the active ingredient. This can result in the approval of  new, differentiated products with tremendous commercial value with much less expensive and much faster route to approval, compared with a traditional development path like 505(b)(1). In other way around it’s a hybrid between traditional full 505(b)(1) NDA and ANDA 505(j). 

Any idea/ candidate for 505(b)(2) needs to be screened at initial stage only. This initial screening is important to establish value proposition of proposed product eliminating/reducing the risk of costly errors. Thus at initial stage, any proposed concept should be screened using four critical points; viz, (a) scientific viability- Does the science in the proposed concept really makes any sense?, (b) medical viability- Does the proposed concept answers any unmet need? Does it add value to the patient? (c) regulatory viability- What kind of clinical, pre-clinical data will be required to get the approval? (d) commercial viability- Does the proposed product has any viable market?  

This 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from a previously approved drug. There are huge opportunities lying in this pathway which can be used successfully. There are different strategies which can be used to apply for 505(b)(2), like (a) new indications, (b) changes in dosage form, strength, formulation, dosage regimen or route of administration, (c) new combination products, (d) new active ingredients, (e) pro-drug of an existing drug.

This pathway provides benefits like (a) relatively low risk because of availability of safety and efficacy data from previous drug approval, (b) lower cost, accelerated development due to fewer studies, (c) comparatively smaller development timeline due to fewer studies and (e) may qualify for three, five or seven years of market exclusivity depending on application.