Well, September saw not only a low for this fiscal year (FY) of forty‑two total approval actions (both full (thirty‑nine) and tentative (three) approvals), but you have to go all the way back to February 2018 to find a lower number of total approval actions (thirty-seven).  And, remember, that number was caused by the approval slowdown due to the elemental impurities issue (see previous stories here and here).  Prior to that, such a low number of total approvals had not been seen since FY 2015 (here).

Again, these are unofficial numbers pending the Office of Generic Drugs’ official posting sometime later this month, but the continued decrease in approval actions is likely going to spark some debate among industry representatives, especially after completion of the GDUFA III negotiations.  I wish I had some explanation for you, but then number of bad (low) months are starting to outnumber the good (high) months in terms of approval actions.  Maybe we will hear something at the GRx+Biosims conference in November.

We will be looking forward to providing FY 2021 totals for all OGD-reported metrics and monthly averages for those metrics likely at the end of October.  You can see the approval actions yourself by searching on September 2021 in the FDA All Approvals listing here.  Stay tuned.