2008 505(b)(2) Approvals

For the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively.  The FDA publishes a list of drugs approved each year and this list for approvals through November, 2008 has a column “505(b)(2) Flag”.  We have found this column to be unreliable – several rows of (b)(1)’s are checked with a (b)(2) flag.  The following table was compiled by reviewing the approval documents for all new drugs approved in calendar 2008; these documents can be found by following the hyperlink for each drug product.

Established NameProprietary NameApplicantApproval

Based on the number of NDA’s that Camargo is compiling for just our clients, we expect 505(b)(2) to dominate the approval list in 2009.  Looking at the number of IND’s we are filing, we expect that by 2012, the percentage of 505(b)(2) approvals will be greater than 90%.