As I was sitting at the AAM’s GRx-Biosims meeting this week listening to the presentation from Dr. Iilun Murphy, Director of the Office of Generic Drugs, I clicked on a link on my computer for the Generic Drugs Program Monthly and Quarterly Activities Report and noticed that the report had been just updated with the data for September 2025 and thus the full FY data was now available. As Dr. Murphy proceeded to discuss OGD approval activity, FY 2025 receipts and other metrics, I realized that much of what I had been predicting in the last half of FY 2025 had indeed come to fruition.

I have already discussed the total original submissions and approval numbers for original ANDAs in my post about Dr. Murphy’s presentation (here) so I won’t bore you by going over those numbers in detail other than to remind you that approvals were only slightly down over last FY but new ANDA receipts were down to 600, 140 lower than last FY’s receipts. Here is a summary of the September statistics and some of the other full year metrics that are, in my opinion, most noteworthy. The full report can be found (here) for you data nerds.

In September OGD fully approved only 40 ANDAs, the lowest number of the FY 2025. Of the 40 approvals, 3 were for first generic approvals and 14 (35%) were first cycle approvals. This is the highest percentage of first cycle approval that I can recall. There were 4 imminent actions included in the full approval numbers. OGD tentatively approved 22 ANDAs, 4 (18%) of which were first cycle approvals and 3 of the 4 were imminent actions. For the full FY, OGD approved 689 ANDAs that represented 92 first time approvals and 137 (19.9%) were first cycle approvals along with 250 tentative approvals of which there were 49 (19.6%) approved in the first review cycle.

FDA issued 88 Complete response letters (CRLs) in September and for the full FY issued 1281 CRLs compared to 1414 in FY 2024. There were no refuse-to-receive letters issued in September and as reported in the blog post referenced above, only 18 RTRs were issued for the full year. This was a noteworthy accomplishment for the industry and represent the lowest number of RTRs issued ever during the GDUFA years which started in FY 2013.

OGD approved 124 prior approval supplements in September and 1489 for the full FY, up from the 1414 issued in FY 2024.

Information requests were at 418 in September and a whopping 5352 for FY 2025 well above the 4298 in FY 2024. OGD issued 198 Discipline Reviews in September and a total of 1949 in FY 2025 down from the 2196 issued in FY 2024.

There was a bit of a shift in OGD workload figures for original applications as the number of Pending ANDAs awaiting FDA action increased from 1259 last month to 1327 in September. Since the number of new ANDAs submitted in September was the highest of the year at 114, this explains the increase in the applications awaiting FDA action. Conversely the number of applications awaiting applicant action decreased to 1891 in September from the previous month’s 1924.

The number of amendments submitted in September totaled 176 with 62 being for major amendments, 63 for minor amendments and 51for unsolicited amendments. The total for FY 2025 was 2087 down from 2305 submitted in FY 2024.

OGD received a total of 932 supplements in September, 787 of which were for CBEs and 145 for prior approval supplements. The total for FY 2025 was 11715 slightly less than FY 2024 total of 11809. Thus, while original ANDA receipts fell significantly over the last year, the number of supplements remained fairly constant and continues to contribute to the high workload of the OGD.

There were 361 controlled correspondences received in September and a total of 3916 for the full FY up about 500 from the previous year. Looks like things might be getting more confusing with new ANDA requirements and a move towards the submission of more complete generic products.

Mean and median approval times for the fourth quarter did a real about face as most of the metrics, with the exception of quarterly mean approval times, went up significantly from the last quarter as can be seen in the chart below.

This up and down bounce we see in the mean and median approval times by quarter is often hard to explain. The interesting thing is that the only metric that has gone down quarter after quarter this FY was the quarterly mean approval times. The median approval time for full approvals has stayed fairly consistent but the mean and median times for tentative approvals really jumped up. The only thing that one might speculate could relate to the larger number of tentative approvals coming from ANDAs in older application cohorts, or applications with unusual regulatory or scientific issues, that finally made it to the tentative approval finish line.

To summarize the FY in review, we saw ups and downs on some important metrics. To me the two most troubling metric drops were in the actual ANDA approvals and ANDA receipts. Hopefully we will see some new players ramp up ANDA submissions in the coming year. However, we know with the government shutdown, no new ANDA submissions will be included in the October figures unless the government opens today or tomorrow which appears unlikely.