Blog & Resources Camargo Blog October 28th, 2009

505(b)(2) Submissions: No RLD

Two weeks ago (10/14/09) I had the pleasure to present at the Drug Repositioning Summit in Boston. I started my talk by asking the audience if a 505(b)(2) application required a Reference Listed Drug (RLD). Most replied affirmatively. My talk was on 505(b)(2)’s without an RLD.

Let’s take a look at the regulation itself:


Notice that there is no mention of where the “investigations” can come from. Many assume it means a drug product previously approved by the FDA. Not true, the data to satisfy approval requirements can come from any source that FDA will view as reliable. In fact, a 505(b)(2) can be used to get a new chemical entity approved:


One of my favorite examples is the 1999 approval of caffeine – an NCE!:


Here is an example of a widely used excipient in the cosmetic industry being approved as an NME:


The following example is a drug that has been used for the treatment of Mediterranean fever since the time of the Greek and Roman empires:


In this blog we have written about DESI drugs being approved through the 505(b)(2) process. Many are approved as NCE’s because there is no RLD. As a reminder, NCE’s get usually 5 years exclusivity.

Some other 505(b)(2) candidates:


Camargo is working with clients in all of the above categories.

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights