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The 505(b)(2) Application for Marketing Approval in the USA

Course Summary

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses.

A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

In this course, we address issues specific to 505(b)(2) applications. We compare the various pathways and distinguish those circumstances appropriate for a 505(b)(2) NDA from those that are not. We identify particular characteristics of 505(b)(2) applications. We refer the learner to other Zenosis modules on NDAs and ANDAs for further details of requirements – for format, content, mode of submission, and FDA review – that are covered there.

Who will benefit from this module?

This module is intended primarily for regulatory affairs professionals who are new to the 505(b)(2) application or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA.

Learning Objectives

  • Identify and characterise the four different pathways by which applications for approval to market a small-molecule drug in the USA may be made
  • Compare the 505(b)(2) application with the other pathways to market and identify its advantages
  • Distinguish circumstances that mandate a 505(b)(2) application from circumstances in which it is optional
  • Specify regulatory requirements that apply to 505(b)(2) applications

Module Outline

Key topics covered in this module include:

  • Pathways to market approval
  • Advantages of 505(b)(2) application
  • Application relying in part on published literature
  • Application relying in part on FDA findings in a previous approval
  • Product modifications compatible with a 505(b)(2) application
  • Bioequivalence of sponsor’s drug and reference drug
  • Reference drug patent information required
  • Market exclusivity for 505(b)(2)-approved products
  • Format, content and mode of submission

Assessment - Multiple-choice assessment.