According to the Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance published yesterday, the Office of Generic Drugs is looking at over 1,712 ANDAs that are pending Agency action. While down a bit from the 1,749 reported at the end of the first quarter, the number jumped from the end of FY 2021 when there were 1,687 ANDA pending FDA action.
The number of ANDAs pending industry action has increased from 1,607 to 1,666 but is slightly higher than the number that were awaiting industry action at the end of FY 2021 (1,637). In addition, mean ANDA approval time has dropped from 39.39 to 34.27 months in the second quarter, but the mean was 30.20 in the last quarter of FY 2021. Median approval time went up slightly, just about one month, from the first quarter figure of 22.16 to 23.13 months at the end of the second quarter.
Mean tentative approval times jumped a little over ten months from 29.03 to 39.37, while the median TA time to approval rose to 30.32 months from last quarter’s 26.68.
So, what do these numbers mean? I think they mean that the OGD needs to find a way to approve ANDAs in the first cycle. There hasn’t been much absolute change in these numbers over the past four and a half years. You can view the current year’s report as well as the reports from FYs 2018 to 2021 here.
