It seems that the pace of approvals in July 2024 slowed and, as a result, our mid-month estimate of possibly hitting 90 approvals was dashed by a late-month drop in approval actions. The OGD did, however, unofficially issue 63 full-approval actions and 12 tentative-approval actions for a total of 75. (As a reminder, at mid-month, the OGD had already issued 39 full-approval actions and 8 tentative-approval actions.) When the OGD releases the official approval numbers and they are close to this total, it will be the third highest total of approval actions in a month thus far in FY 2024.
We know from experience that approvals are difficult to predict. Trust me, I have been doing this for 40+ years and, even during my ten years at the FDA, which had just started at the time of the passage of Hatch-Waxman, the crystal ball never really worked as a predictive tool. We did rush around in the waning days at the end of slow months to see whether we could push a few more approvals through the end of the process; however, there are always a number of factors that may intervene and these result in the ups and downs in approval actions seen from month to month. For instance, the OGD might have several ANDA applications ready to approve and, at the last minute, a bad inspection may hold them up. A firm may need to make a last-minute change in process or API source because of a problem found at one of its suppliers, or some other unforeseen issue pops its head up at the last minute (like the nitrosamine issue that delayed many ANDA approval actions for months and months). That is the reality of the global field on which the drug approval process plays.
The OGD has always said there will be good months and some bad months. July looks like it is on the good side, just not as good as it looked in the middle of the month.
