Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really? Don’t know exactly how that happened because our estimates are usually below the totals. Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals. However, after looking at the FDA All Approvals list and after further exhaustive study of the Orange Book listings for products listed as tentatively approved this month to try to find the discrepancy, it seems like a group of bendamustine ANDAs that were previously and possibly erroneously reported as approved were actually revised to tentatively approved. This would account for the twenty-three TAs that I previously counted as TAs; there is also one ANDA that appears to be missing from the official numbers as the All Approvals webpage does list eighty-three full approvals. Thus, it appears that, this month, the discrepancy in the figures is partly based on past FDA errors, but we still don’t know what happened to the one missing full approval on the OGD “Official” report that is not accounted for.
This is still a good month for the OGD, whether the real number is actually 106, 99, or 105. Because I am fairly confident that I am correct, I am going to use the 83 number as the full-approval number for projections. Thus, if we look at the estimates based on the first five months of FY 2019, we predict that total full approvals will hit about 1,058 by the end of the FY. As a reminder, the previous high was 781 in FY 2018. If this holds true, then we are looking at four consecutive years of record numbers of full approvals.
The number of new ANDAs received in February was seventy-six, which (if projected for the full FY) would result in a total number of receipts of 945, which, if approvals and receipts continue at the current rate, would be the first year during GDUFA where approvals exceeded receipts!
The updated statistics for January include the following interesting issues:
In January there was only one refuse-to-receive (RTR) – this is a milestone as this is the lowest number of RTRs issued in any month. Maybe the industry is getting better!? There were 162 complete response letters issued in February.
Of the eighty-one full approvals issued in January and February, seventeen of them (or about 21%) were first-cycle approvals and four (or about 19% of the twenty-one tentative approvals) were reported as being completed in the first review cycle.
Submission of CBE supplements and Controlled Correspondence in January hit a high for this FY at 679 and 264, respectively. However, the number of amendments submitted to ANDAs were at the lowest for this FY so far at 180 (previous high for FY 2019 was in October at 225).
There were no other surprises seen in the stats! To see the updated January and new February report statistics, click here.