Generics Statistical Report Partially Updated


Today, the Activities Report of the Generic Drug Program 2015 received its first update since March 2015.  However, it was only a partial update, as no information relative to amendments received for original or supplemental applications were posted.

With some of the June numbers obtained directly from the Office of Generic Drugs (OGD), here are the Fiscal Year to Date Approvals, Tentative Approvals, and receipts of original applications:

FY 2015 through June

ANDA Approvals     281

Tentative Approvals     78

ANDA Receipts    455

We can clearly see that receipts are still outpacing approvals, which as was mentioned in yesterday’s blog (here), adds to the overall backlog.  If we project the 9 month totals for the full FY, we would anticipate 375 Approvals, 104 Tentative Approvals, and 606 original ANDA receipts.  Last year, Approvals totaled 409, there were 91Tentative Approvals, and there were 1473 receipts of original ANDAs.  So, if the numbers hold true, the backlog will still be expected to increase but at a much slower rate.  If OGD hits about 60 approvals per month for the last three months of the FY, then they will hit 461 approvals for the year, which would be the highest number of approvals for a FY since the implementation of GDUFA (FY 2013 has 440 approvals).

Very interestingly, the average number of complete response letters (CRLs) has dropped from 105 in FY 2014 to 92 through May in FY 2015.  This is a bit troubling, since the number of staff has increased dramatically and one would think that OGD must be cranking out more approvals (which they are), as well as more CRLs (which they are not).

OGD refused-to-receive a total of 134 ANDAs (average of 17 per month in the first 8 months of FY 2015) and reviewed 621 DMFs during the 8 months of reported data this FY.  In addition, OGD received a crushing number of CBE supplements that totaled 3449 (average of 431/month) during the first 8 months of this FY.  They also received 329 (average of 41/month) PAS supplements that are under GDUFA goal dates for cohort year 3.  Post CR meetings requests are averaging 17 per month versus 7 per month last FY (note that the numbers reported for this category are cumulative by month, but in the FY 2014 report, the months were erroneously totaled).

The numbers show that OGD is heading in a positive direction, but still has a lot of work to do to get its machine powered up to meet the demands of its workload.