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Each year, the Food and Drug Administration (FDA) approves approximately 120 new drug applications (NDAs). But contrary to what many might believe, a majority of these NDAs are not, in fact, new chemical entities (NCEs).

Instead, many sponsors of these NDAs are leveraging data and information already known about existing FDA-approved drugs to develop new applications. These products make use of known active pharmaceutical ingredients (APIs) in order to develop new dosage formulations, strengths, API salts, dosing regimens, routes of administration, indications and combination products. These products are commonly known as Section 505(b)(2) NDAs.

The Section 505(b)(2) NDA is one of three FDA pathways for drug approval. The provisions of Section 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved and reference listed drug. It represents an appealing regulatory strategy for many pharmaceutical manufacturers.

These products offer some significant advantages over other more expensive, time-consuming and complex options – plus advantages over generics as well. While they may not offer the same kind of home run potential as NCEs, they can be a way for investors and manufacturers to get on base and make a strong return on their investment of time and money. But as always, Section 505(b)(2) NDAs will come with their own challenges and risks in gaining FDA approval.

In this eBook you’ll hear from our contributors about:

  • 505(b)(2) products and the next generation of the U.S. pharmaceutical industry
  • Risks and challenges with 505(b)(2) approval
  • What’s on the horizon in 2020 for manufacturers and investors
  • And much more