With 11 reporting days of August behind us and 11 to go, OGD has issued 31 full approval actions and 2 tentative approval actions.  If the current rate holds true for the rest of the month, OGD could be back to well over 60 total approval actions in August.

We have seen a slowdown of approval actions over the past few months, with July reporting the lowest number of approval actions this entire FY.  Could this be a turnaround?  We will have to wait to see.

Reporting is gathered for this post from the FDA’s All Approvals list (here) for numbers reported through August 16, 2021.  No ANDA approval actions have been reported yet for the 17th,, 18th , or 19th.   Once we are in September, we will update you on the status of approval actions, as we know that (just like GE might have said), for approvals, “progress is our most important product!”.