August has brought a lot of heat over most of the US. So far this month, the descriptor of “hot” does not appear to apply to the pace of ANDA approval actions. Maybe the review folks from FDA are escaping the heat on vacation but through August 15th, OGD has posted only twenty ANDA approval actions and three tentative approval actions.
If the numbers do not improve quickly, the number of approval and tentative approval actions for August are likely to both be the lowest number for any month in FY 2026 thus far!
We will keep an eye on this development as it is indeed a marked shift from the recent increased pace of ANDA approval actions we have seen over past couple of months or even the monthly results for the rest of the FY. Maybe there are some lurking ANDA approvals sitting in the system, ready to pop out! We sure hope so!
