Reality check on 505(b)(2) NDA Approval Pathway

In 1984, the 505(b)(2) approval pathway was created to permit FDA approve new drug applications (NDAs) based on data from previously approved drugs and therefore streamline the development and approval process of new drug applications (NDAs).

The 505(b)(2) pathway is very attractive to drug makers because it can shorten their development and cost timelines. Additionally, applicants may qualify for three to five years of market exclusivity. From 2009 to 2015, 63% of 451 original new drug applications that have been approved by FDA were via the 505(b)(2) pathway.

However, the mean approval timelines for such applications was nearly five months longer than that for new molecular entities (NMEs). The delays in approval were attributed to the fact that only limited number of 505(b)(2) applications received expedited review designations from FDA when compared to NMEs during the time period studied. Additionally, many 505(b)(2) applications were incomplete and FDA couldn’t finish their review before receiving the additional information.

As with any drug development program, it’s important to engage proactively with the FDA to better understand the data needed to bridge a 505(b)(2) program with the approved reference product before filling it the application and really benefit from the advantages of 505(b)(2) benefits.

Scroll to Top