While it has been over a full month waiting for official approval numbers, receipts and complete response statistics for November of FY 2022 to post, and after bemoaning the delay in one of posts yesterday, they popped up either overnight or early this morning. The full approval actions hit 67 (we unofficially missed by one (66 previously reported)) and official tentative approval actions were reported as 8 (we only saw 6 when we posted on December 5th) for a total of 75 total approval actions for November. Of the 67 full approval actions, 8 were identified as first-time generic approvals.
OGD also reported the issuance of 168 complete response letters and that seems about average. The Agency reported receiving 51 ANDAs in the month of November which more than twice beat the October reported ANDA receipts of 24.
We report further on the remainder of the November statistics once the FDA scrubs the numbers and post them (here). Given the up and down nature of what we have seen officially from FDA and what we unofficially pick up from the daily approvals list and FDA’s All Approvals list it looks like we are going to see a rocky FY 2022.