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Blog & Resources Camargo Blog January 2nd, 2013

2012 505(b)(2) Approvals—Record Year

Nice going! 2012 saw a record number of 505(b)(2) drugs approved – 47. As is usual at this time of the year, I have prepared a listing of all of the approvals. This year, I have made the listing more useful – the table is now sortable and now contains a hyperlink to both the FDA approval letter and, where available, the review division’s review documents (formerly called the Summary Basis of Approval – SBA, a term still widely used). I welcome your suggestions for improvements. I am working on developing this table for 2004 -2012 – stay tuned.

So, how does this performance stack up against all other NDA’s? I tread carefully here. I could do a count myself, like I have done for 505(b)(2)’s. Yet, I’d like to use FDA statistics as the numerator in any comparison. FDA has PDUFA reporting requirements and gives out various numbers throughout the year. In 2008 the FDA added NDA and BLA approvals together. That said, the following chart was presented by Dr. Jenkins on December 10, 2012, which presents 31 NME’s as of 11/30 (but he doesn’t indicate whether the NME’s include 505(b)(2) NME’s – there were three 505(b)(2) NME’s approved in 2012). Given this caveat, we can say that about 50% more 505(b)(2)’s were approved than 505(b)(1)’s. A very nice year indeed for our friends and clients engaged in 505(b)(2) development.



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