What is 505(b)(2)?
What Industry and Bench Scientists Need to Know: Part 1 of 3

What do you do if you discover a new use for an old drug? Perhaps you have created a new formulation, a new dosage form, or a prodrug ? In this series we will discuss how the FDA treats these discoveries as new drugs under the 505(b)(2) regulatory pathway.

The 505(b)(2) new drug application (NDA) is one of two abbreviated pathways that the U.S. Food and Drug Administration (FDA) can employ for drug approval.  The operative word here is “abbreviated”.

This pathway represents an appealing regulatory strategy for many sponsors of new drugs. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug. As a result, this regulatory pathway gives the FDA express permission to rely on data not developed by the NDA applicant.¹

In its 2019 Guidance to Industry: “Determining whether to submit an ANDA (Abbreviated New Drug Application) or a 505(b)(2) Application”, the FDA explains that a 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant.¹ This can shave time from your drug development timeline.^2,3

Below is a brief list of drugs approved by the FDA under the 505(b) (2) regulatory pathway in 2020. How many of these are you familiar with?

Drug	Type	Company
Diazepam nasal spray	New dosage form	Valtoco
Octreotide acetate injection	New formulation	Bynfezia
Pemetrexed diacid solution	New formulation	Pemfexy
Cysteamine Bitartrate DR granules	New dosage form	Procysbi
Meloxicam injection	New dosage form	Anjeso
Romidepsin RTD* solution	New formulation	Teva
Monomethyl fumarate DR** capsules	New active ingredient	Bafiertam
Celecoxib oral solution	New dosage form	Elyxyb
Clobetasol propionate topical solution	New formulation	Impeklo
Apomorphine sublingual film	New dosage form	Kynmobi
Deferiprone DR tablets	New formulation	Ferriprox
Minocycline 1.5% topical foam	New formulation	Zilxi

Source: https://pharmacaptions.blogspot.com/p/505b2-approvals-list-2020.htm, * Ready to dilute, ** delayed release

1. Determining whether to submit and ANDA or a 505(b)(2) Application: Guidance for Industry. US department Health and Human Services. Accessed at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.  August 9, 2021
2. The Current State of Play in the Pharmaceutical Industry for 505(b)(2) New Drug Applications. By Matthew L. Fedowitz. Accessed online at https://www.505b2.org/publications/the-current-state-of-play-in-the-pharmaceutical-industry-for-505b2-new-drug-applications#/. August 9 2021
3. Abbreviated Approval Pathways for Drug Products: 505(b)(2) or ANDS? CDER Small Business and Industry Chronicles (SBIA) Chronicles. September19, 2019. Accessed on line at https://www.fda.gov/media/130898/download. On August 9, 2021

About the Author:

Kenneth Duchin, PhD. is an experienced clinical pharmacologist with extensive drug development experience in a broad range of therapeutic areas (e.g., oncology, urology, diabetes, CNS, CV, GI). He has led several registration programs and authored regulatory documents to support regulatory filings.

Contracting with Omar Consultants:

Omar Consulting Group, LLC helps clients reach the goal of executing successful clinical trials and regulatory strategy that will meet the provisions of regulatory authorities.

Submit your request for an initial consultation here.