Late Wednesday afternoon, the FDA posted official metrics for the items mentioned above. This was a p quick turnaround for these figures as they usually come out about the middle of the month. The OGD report (here) lists 61 full approval actions (we missed on our predictions by 1), which included 7 first generic approvals, and 19 tentative approval actions (we missed by 2 but you can’t blame us as the other two still do not appear on the FDA’s All Approvals list as of 6PM on Wednesday) for a total of 80. That figure has not been reached since just a little over a year ago when, in December 2020, OGD issued a total of 85 full and tentative approval actions.
I guess that 61 was the flavor of the month as OGD not only approved that number but also received 61 new ANDAs in January. Complete Response Letters (CRLs) jumped back up to 195 after last month’s 108. The 195 number was the highest since March of 2020 when 195 were also issued by OGD. The record high for CRLs came in July of 2018 when 357 were issued. The current usual is around 150-160.
We will post more on the January metrics towards the end of February or beginning of March when OGD comes out with its official update for you number nerds like me.
