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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.