We were close with our estimates for February approval actions, but the FDA reported one fewer full-approval action than we did (fifty-nine vs. sixty) and, upon review, note that it was because one of the ANDAs was listed in a separate line item as an action.  Sorry we missed that!  Of the fifty-nine full-approval actions, seven were reported as first-time ANDA approvals.  In terms of tentative-approval actions, we reported eight and the OGD reported twelve.  The fact is that we could not have caught this discrepancy because there are still only eight tentative-approval actions listed in the FDA All Approvals report (here).  Not sure how that can still be but, as of 11 a.m. on March 25, 2022, that is the case.  So, in total, the FDA issued seventy-one approval and tentative-approval actions in February.

With five months gone in FY 2022, if the rate of approval remains the same, the OGD should wind up with about 648 full ANDA approval actions for this FY, slightly less (4.5%) than the 678 approved last FY.

Complete response letters were tallied at 141 in February, the low so far this FY.  New ANDA receipts were the second lowest at fifty in February (the previous low was twenty-four in October).  Projecting the current rate of receipts, it looks like the OGD will receive about 770 ANDAs in FY 2022.  It appears we are headed to another year where receipts outpace approvals by more than 100.

Looking back to the updated January stats for refuse-to-receive (RTR) actions, it seems that three is the magic number for the FY so far as, for the fourth straight month, the OGD has issued three RTRs.  The OGD also acknowledged eighty-three new ANDAs, the highest number thus far for the FY, likely in response to working through the acceptance reviews for the large number of new ANDAs (135) submitted in December 2021.

Of the sixty-one full-approval actions issued in January, the OGD reported seventeen (28%) as first-cycle approvals.  This is a surprisingly high number and all of us in the industry hope to see this, for now, as a consistent figure that will eventually climb even higher.  On the other side of the coin, of the seventeen tentative-approval actions, only one (6%) was approved during the first review cycle.

Changes being effected (CBE) supplements sunk below 700 (643) for the first time this FY, and prior approval supplement submissions were also the lowest for the FY at ninety-five.  Controlled Correspondences jumped back over 300 (318) after slipping below that storied number to 252 in December.

The OGD’s full activity report can be reviewed here.  We will be reporting more on the February and March stats as those become public.