Some Bright Spots on First Cycle Approvals

In browsing the FDA generic approvals for October so far, there are some ANDA numbers that immediately caught my eye.  ANDA 210064, which was tentatively approved on October 12, 2017, was, according to the tentative approval letter (here), received by FDA on December 16, 2016.  That is an 8-month tentative approval.  There is another instance, ANDA 210117 for allopurinol tablets, that was received around the same time (no approval letter is available to discern the actual submission date), but that was a full approval which appears to have been granted in about 8-10 months.

There are several other ANDAs on the approvals list for October with ANDA numbers in the mid to high 209000 series that would also appear to be potential first cycle approvals, which would bode well for both industry and FDA.  However, there are also many in the 202000 to 207000 series range which means approvals are aged 4-& years old, which does not do much for median approval times.

Seeing median and mean approval times by cohort year will shed additional light on the true progress in the OGD review process and potentially how well industry is doing in improving the quality of submissions. And of course, timely data on first cycle approvals will be very useful as a barometer of success.