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2013 505(b)(2) NDA Approvals

2013 appears to be a challenging year for FDA NDA approvals.  FDA’s John Jenkins reviewed the  NME NDA and BLA approvals through November 2013, showing that 25 such products were approved (see chart below).  These 25 approvals are 505(b)(1)NDA and BLA’s.  Generally, this performance was seen as disappointing, but readers of this blog know that the number of NDA’s has been expected to decrease.  Big Pharma is transitioning to BLA’s, but considering the huge investments needed to conduct the pivotal studies, the numbers are going to be few.

2013 NDA NME/BLA Approvals thru 11/30/2013

We’re happy to see that 505(b)(2) activity continues to be healthy with 38 NDA’s approved through the end of the year. The listing of approvals is available here where you can also see all 505(b)(2) approvals since 2004.  As we note each year, the FDA does not track 505(b)(2) approvals as part of their PDUFA goal reports.

505(b)(2) 2004-2013

The PDUFA review time has been 10-11 months during most of the reviews of the 2013 approved 505(b)(2)s.  As the following chart illustrates, there are many approvals within the PDUFA goal dates.  Clearly, there are some that take a very long time.  For 2013 the ‘winner’ is Duchesnay Inc.’s doxylamine succinate and pyridoxine hydrochloride delayed-release tablets which took 2991 days from the initial submission.  This product is the successor to Merrell-Dow’s Bendectin Tablets which was voluntarily removed from the market in the early 1980’s due to the high litigation cost to defend against lawsuits alleging teratogenic effects.  Benedectin was preceribed to pregant mothers to treat morning sickness.  All lawsuits have been positively resolved in favor of no effect.

Other lengthy reviews can be mostly attributed to CMC-related deficiencies.  This is the reason most 505(b)(2) NDAs have been delayed for many years. Many sponsors think that a 505(b)(2) is like a 505j (generic) or a 505(b)(1) and try to model their development accordingly.  Such a  big mistake.  Thus, Merck, Sharp & Dohme’s 505(b)(2) application for Ezetimibe and atorvastatin Tablets took 1321 days to review.  MSD modeled a 505(b)(1) and failed to provide in vitro bridging data.  They were consist with their modeling when they submitted Omeprazole and sodium bicarbonate powder for oral suspension and interacted with FDA for 1888 days.
2013 approval timeframe


Stay tuned for more analyses over the next few weeks.