As a follow-up to our August 5, 2026, post here announcing June 2026 Official Generic Drugs Program Monthly and Quarterly Activities, I promised to provide the mean and median ANDA approval times when OGD updated the Dashboard for June. Well, here is the new chart containing the third quarter for those metrics.
The mean and median tentative approval times also follow the same pattern as those seen for the mean approval times, albeit that the absolute difference in the third quarter being slightly larger than the previous two quarters. As we have noted in previous posts, these quarterly figures present only a snapshot in time. The difficulty in interpreting their significance is a task itself given the continuous up and down bounces. Looking back on previous FY reporting of these metrics does not really offer a clearer window into the significance of these bounces, especially over the last two FYs. One might hope to see a straight line decrease in the mean or median approval times over the course of a few years however, that is somewhat buffeted by the differing cohort years represented by the applications approved in a given FY year.
