With 5 business days and 6 reporting days until December 1st, OGD already has booked 79 full approval and 23 tentative approval for a total of 102 approval actions so far in November.  This could be good news, as a trend towards more record numbers of approvals is now evident.  We have had two consecutive months with new records, and this may be number 4 in the last 12 months!

The better news is that, thus far in calendar year 2018, there have been 82 first generic approval (here ).  Typically, first generic approval starts the process of lowering drug prices and, as more ANDAs gain approval, the prices really begin to fall.

We can’t wait for the final official OGD approval numbers to be published to see if a new record will indeed be set, which usually happens around 8-10 days into the new month.  With about 4000 ANDA either in the hands of OGD or waiting for replies to Complete Response Letters from the Agency, there are plenty of opportunities for more records to be broken.  The 10-month GDUFA II review clock also will play into speeding up the overall approval times and numbers even if second or third cycle approval are required.

It appears from the assigned ANDA numbers (please realize this is a crude estimate or a WAG as some may call it) that about 15-16 ANDAs might have received either first cycle approval or tentative approval so far in November.  That would mean that, in November, the first cycle approval rate may be around 14-16%.  That is the good news, however, the bad news is that there are several very old ANDAs that received approval, which will not bode well for median or mean approval statistics.

Please see the FDA’s All Approval page (here) for November to see for yourself!