January’s Big Chill Places Some Strain on Approval Actions


The Washington DC. / Maryland “snowmageddon” event causing the closure of the Federal Government for a few days may have resulted in a dip in ANDA approvals in the first month of calendar year 2016.  The Office of Generic Drugs (OGD) fully approved 42 ANDAs and tentatively approved 17 ANDAs in January.

Four months into FY 2016, OGD is averaging 58 approvals a month, which is significantly higher than in any of the GDUFA FYs to date.  At this monthly rate of approvals, OGD should hit close to 700 (696 to be exact) by the end of year four of the GDUFA program.  The previous high for post-GDUFA ANDA approvals was 492, which came in FY 2015.  Hopefully, if this is a down month, we may see even more that the straight line projection predicts.

OGD has been averaging about 17 Tentative Approvals (TA) a month, which is also at a pace that exceeds what we have seen in years 1-3 of the program.  This is good news since TAs usually translate into approvals.

The final number of receipts were not yet available for publishing, but will be reported upon as soon as that number is reported by OGD.

Take care when reviewing the Generic Drugs Activity Report for FY 2016 online, as the totals column only totals the first two months of activity. (I guess OGD may be spending more time on review and approval activities than monitoring the reporting of their activity.)  This can also be seen in the lack of data on many of the categories of the metrics OGD has previously reported.  For instance, while Changes Being Effected (CBE) supplements are reported for the first two months of the FY, they are not provided for month three (December).  It is interesting to note that the number of CBE supplements fell by almost 50% in November (373) as compared to 625 in October.  FY 2015 saw an average of about 460 CBE a month, which is close to where the reported two-month average sits now.

As I noted previously, FY 2016 appears to be a big improvement, but will it be enough of an improvement to satisfy the generic drug industry as they move into the meat of negotiations for GDUFA II?