2010 505(b)(2) Approvals
- Posted by Ken Phelps
- On January 6, 2011
- Categories: 505(b)(2) Development, Commercialization, Prodrug, Product Selection and Planning, Regulatory Strategy & Submissions, Services
We join everyone else this time of year and develop a list – ours is a list of FDA approvals made under 505(b)(2). As widely reported (WSJ article here) FDA reported that approvals were down in 2010.
Frankly, it’s hard to tell what the figures are, let alone mean. The Agency sometimes includes approval of a biologic, but not all of them (with no explanation). The Agency also tries to separate 505(b)(1) and 505(b)(2) approvals but isn’t accurate. In 2010, as in past years, several approvals classified by the FDA as 505(b)(1) were based extensively on the literature. One division in particular seems to view all submissions as 505(b)(1)’s even when the majority of the data is based on public data.
So, as usual, when I develop my list of 505(b)(2) approvals I only list those drugs where the Agency specifically indicates that the approval was under 505(b)(2). Thus, in my list you will find a hyperlink with the approval date — this hyperlink jumps to the actual approval letter. Using this method, I am likely underreporting 505(b)(2) approvals.
Our tally is 22 505(b)(2) drug product approvals in 2010. According to the WSJ, 21 drug products were approved under 505(b)(1).
In 2010, there were no New Molecular Entities approved under 505(b)(2). Several NME’s were approved in 2008 and 2009. And, although there are several pro-drugs in development, none were approved in 2010.
As always, errors are mine. If you see one, please bring it to my attention.