Well, here we are at the end of Fiscal Year (FY) 2024 and, because we likely will not see official approval action totals for the last two months of the FY until sometime in November, we will take a stab at giving you the best estimate we can.
For September, the unofficial approval actions look like this – OGD issued 63 full approval actions and 10 tentative approval actions for a total of 73. The total official full approval actions are posted on the FDA webpage only through July 2024 (and stand at 566). Our unofficial full approvals for August were 66 and for September, 63, to round out the rest of the FY. Thus, the full FY year total of full approval actions should be just about 695 (there could be some small up or down movement in the numbers from late reported data).
In the previous 5 FYs, totals for full approvals were 782, 722, 679, 737, and 935, respectively. I believe the trend is evident and, while there was 1 year (FY 2021) with a lower number than the projected FY 2024 total, the downward trend is evident. We will await the official totals for August and September once OGD publishes the data and will revise the final number accordingly if there is a discrepancy between the numbers we report here and the official totals.
The other number of significant importance is the number of new ANDAs being submitted and, because we have no transparency yet to August and September numbers of new ANDA submissions, we will have to wait until the official numbers are posted. We will reserve commentary on this issue until such time that we have access to the official numbers – which might be revealed at the upcoming FDA’s GRx-Biosims meeting later in October. If that is the case, we will report back with that data and our thoughts on the meanings behind the numbers.
Until then, feel free to provide us with comments regarding what you are seeing. All information will be reported without regard to the submitter’s identification. You can make comments directly to me at r.pollock@lachmanconsultants.com. I look forward to hearing your observations and comments.
