The OGD published its official June 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here) and it comes with some good news on approval times for the quarter but some not-so-good news in terms of new ANDA submissions. Please review the entire report at the link above to see all of the metrics reported by the OGD.
Let’s start out with the approval statistics. The OGD fully approved 67 new ANDAs. Of those 67 full approvals, 9 were for first-time generic approvals, 18 (26.9%) were approved in the first cycle, and 10 of the 18 first-cycle approvals (56%) occurred through the imminent actions enhancement made under GDUFA III. The nine-month total of new ANDA approvals stands at 550 and, assuming the average monthly approvals remain the same, the OGD should approve about 733 ANDAs in FY 2025, which is somewhat better than the 694 it approved in FY 2024 but a drop from the 782 ANDAs approved in FY 2023. The OGD also tentatively approved 22 ANDAs, 6 of which (27.3%) were first-cycle approvals. Three of the tentatively approved ANDAs approved in the first cycle were also part of the imminent action enhancement program mentioned above. The percentages of first-cycle approvals are higher than usual for both full and tentative approvals, providing an indication that the OGD is making its best effort to improve its first-cycle approval percentages.
The OGD, however, issued only 85 complete response letters (CRLs), the lowest in any month so far this fiscal year. Perhaps the lower number of CRLs is indicative of the increase in first-cycle approvals as, perhaps, firms are getting it right the first time around. I think we’ll need to see more data in future months before accepting this as gospel. However, there was only one refuse-to-receive letter issued in June and only 15 issued thus far this fiscal year compared to 24 for the full FY 2024, so that is a good sign!
The OGD issued 36 acknowledgement letters in June, indicative of the lower number of new ANDA submissions being received (see below for additional discussion). The OGD issued 113 approvals for prior approval supplements. In addition, the OGD issued a total of 429 information requests (248 for original ANDAs and 183 for supplement submissions). The OGD also issued 203 discipline review letters (DRLs), which was the second highest for FY 2025 behind the OGD’s issuance of 313 DRLs in March.
Looking at the general overall ANDA workload for the OGD, pending ANDAs awaiting FDA action dropped once again from 1,289 in May to 1,266 in June! This is the lowest number of ANDAs in the FDA’s court that we’ve seen since this metric was first reported under GDUFA III in FY 2023. The highest number of ANDAs pending FDA action that we’ve seen was in December 2022 (FY 2023) when the number stood at 1,678—a remarkable drop of 412 ANDAs in the OGD’s workload statistics.
The number of ANDAs awaiting applicant action currently stands at 1,949 (565 for tentative approvals and 1,384 for CRLs awaiting applicant response), down from 2,177 in October 2022, the first month of FY 2023.
Now let’s talk about the receipt side of the house where new ANDA receipts continue to raise some concerns. The OGD received 36 new ANDAs in June and a total of 363 new ANDAs in the first nine months of FY 2025. If we extrapolate using the current average monthly ANDA receipts, the OGD would be projected to receive only 524 new ANDAs during the entire FY 2025 compared to the 740 it received in FY 2024 and the 733 it received in FY 2023. We know there has been quite a bit of consolidation in the industry and that firms appear to be directing greater percentages of their research-and-development spend in complex generic products. Also, as we mentioned in previous blogs, firms are reallocating resources for the development of more profitable biosimilar products rather than towards commodity generics. This is an issue that needs to be evaluated in the face of declining ANDA submissions. Continuation of this decline could see FDA generic resources reallocated to other FDA program areas that are increasing in workload. With GDUFA IV user fee reauthorization negotiations just getting underway, the question is: what impact will the lower numbers of new ANDA submissions have on the generics program in both the short term and long term?
Please ponder that question as we now look at the other newly reported OGD receipt metrics. In June, the OGD received the highest number of ANDA amendments reported thus far this fiscal year at 211 (82 major amendments, 56 minor amendments, and 93 unsolicited amendments (the highest monthly submission of unsolicited amendments this fiscal year, by the way)).
Supplemental application submissions continue to be strong with 1,105 (the highest number this fiscal year) submitted in June; broken down by type, there were 928 changes-being-effected supplements and 177 prior approval supplements. Controlled correspondences are also keeping the OGD busy with 375 (the second most this fiscal year thus far) being submitted.
Now for the really good news! For the third straight quarter, OGD approval times have all decreased! Please have a look at the table below for the numbers.
This is the first time that we’ve seen a drop across the board for both approvals and tentative approvals in both mean and median ANDA approval times for three straight quarters since these metrics have been reported. Hopefully this trend will continue.
Well, that’s it for now! Enjoy the rest of your summer and we’ll be back with more statistics as they become available.
