Here are some of the highlights of the recently issued Generic Drugs Program Monthly and Quarterly Activities Report for July 2025. For more details or to review the full report, please click here. Our analysis appears below.
As we noted in a previous post (here), the OGD fully approved 52 ANDAs in July 2025, which is the lowest number of approvals officially reported in any month in FY 2025. In another blog post (here), we reported (albeit unofficially) that the OGD fully approved only 47 ANDAs in August, which (if this number becomes official) will take over the dubious distinction of being the lowest monthly total for FY 2025. The number of tentative approval (TA) actions issued in in July was reported by the Agency as 19, and we appear to have been off the mark by 5 as we unofficially reported 14 from the daily approval data report by the OGD. However, upon review today of the FDA’s All Approvals site (here), we find only 13 tentative approvals listed, which is what we would have expected (this is due to one of the tentative approvals being designated as Orig2, which means that it was the second TA issued for the product). Thus, our call of 14 was actually correct when it comes to unofficial approval actions because the FDA All Approvals list, when released, will remove any multiple TA letters issued for the same product. It is, thus, not at all clear why the official stats for July list 19 TAs. This discrepancy deserves an explanation.
After that rather tortuous explanation, let’s look at what else we know about July ANDA approval actions. Of the 52 full approvals, 5 were for first-time generics, 9 (17.3%) were first-cycle approvals, and 3 of the total were approved under the imminent-actions enhancement of GDUFA III. I’m a bit reluctant to further parse out the TAs due to the discrepancy in the numbers reported as discussed above. Hopefully someone at the OGD will read this post and either revise the total number of TAs or shed some light on the discrepancy.
The OGD issued 127 complete response letters (CRLs), which is the highest number issued in any month in FY 2025 thus far. The official monthly average for CRLs in the first ten months of FY 2025 was 111. ANDA refuse-to-receive actions were at 2 in July, and the OGD acknowledged 35 new ANDAs during the month.
The OGD approved 115 prior approval supplements in July (the 10-month average is 126.3). Information requests were the lowest thus far this fiscal year with only 414 issued (227 for original ANDAs and 187 for supplements). The 10-month average is 449.5. Discipline review letters issued totaled 142 (the 10-month average is 159.8).
Of significant importance is the measure of the OGD’s ANDA workload, which shows that the number of ANDAs awaiting FDA action fell once again to the lowest yet of 1,238; this represents the fourth month in a row that a new low was reached. The OGD started out FY 2025 with 1,480 applications in its queue. The number of ANDAs awaiting applicant action took a bump up to 1,967 from the previous month’s 1,949; FY 2025 started off with 1,941, which suggests that applicants are not responding to CRLs as quickly as the OGD is issuing them and/or the number of TAs that cannot yet be responded to (because of patent or exclusivity issues) is increasing. The breakdown between CRLs and TAs awaiting applicant action is 1,396 and 571, respectively. These categories started out the fiscal year at 1,413 and 528, respectively.
Now, let’s take a look at the receipts side of the house. The OGD received 55 new ANDAs in July (monthly average for the first ten months is 44.8 ANDAs), which means that July was a good month for receipts. The FDA reports that, of the 55 new ANDAs received, 7 were for complex products.
Sponsors submitted 198 amendments (categorized as 53 major, 64 minor, and 81 unsolicited) in July. It’s interesting to note that June and July saw a significantly higher number of unsolicited amendments submitted (93 and 81, respectively). These two months pushed the 10-month average to 59.7. This is significant since unsolicited amendments typically reset the GDUFA application goal date depending on when they were submitted in the review cycle.
The OGD received 1,040 supplements in July (846 were for CBEs and 194 were prior approval supplements). Also, the number of controlled correspondences received remains in the mid-300s, with 347 submitted in July. It seems that applicants still have a lot of questions and need clarifications on certain ANDA requirements, and they want to receive OGD feedback before embarking on paths that might not be found acceptable by the OGD.
With less than one month left in FY 2025, we’ll be providing more details on the OGD metrics as they become available.
