It has been a slow go for the first half of September, which is the last month of FY 2025. So far this month, there have been just 17 full-approval actions and 4 tentative-approval actions posted on the FDA daily approval page (here). This is the lowest number of approval actions midway through any month that I can remember in a very long time. If the rest of the month’s approval actions remain at the same pace, this will likely translate to the lowest month in the modern GDUFA II and GDUFA III era, since February 2018 when there were 32 full approvals and 15 tentative approvals.
September 2025 could harken back to the first three years of GDUFA I (FYs 2013, 2014, and 2015) when the program was getting off the ground. At this time, the numbers were often as low as this each month; total monthly full approvals averaged 37.25 per month and tentative approvals averaged just 8.5 per month. You can search for those years from the bottom of the Generic Drugs Program Monthly and Quarterly Activities Report (here).
Perhaps September 2025 will be an outlier; however, we noted that the unofficial full-approval numbers for August 2025 were at 47, which is another low for the fiscal year. Unless there are a lot of late approvals posted for August, and/or September has a strong second half, this has the potential to be the third month in a row that approvals have continued to decline. We will let you know in a couple of weeks what the last chapter of FY 2025 looks like.
