With the official August 2026 numbers reported, let’s take a walk on the wild side and try to predict what the full FY 2026 ANDA approval numbers may look like as we won’t see the full FY 2026 official report on approved ANDAs until sometime in November.

Data from the FY 2026 Generic Drugs Program Monthly and Quarterly Activities Dashboard Report (here) for August shows that OGD has approved the fewest number of original ANDAs at 41 behind only May’s 42 ANDA approvals. The total number of full approvals for the 11 months through August is 650. The September 2026 unofficial full ANDA approvals gathered from the FDA daily approval page (here) looks to be 47 (this figure can change based on late reported approvals). Thus, we anticipate the total FY 2026 number of ANDA full approvals to be 697 (650 + 47) which would be a tad more than the 689 approved in FY 2025 and 3 more than the 694 approved in FY 2024 but well below the 752 approved in FY 2023. So, what we appear to be seeing is that OGD’s rate of ANDA approvals has plateaued over the past three fiscal years

Of the 41 full approvals in August, five were for first time generics and four (9.7%) were first cycle approvals (the lowest percentage of first cycle approvals in any other month thus far in FY 2026). As far as tentative approvals go, in August OGD issued 11 tentative approvals of which one (9%) was a first cycle approval. This too was the lowest percentage of first cycle approvals for tentative approvals in a given month thus far this FY. Why are we seeing fewer first cycle approvals? Good question. While we don’t have any concrete answers, we speculate that compliance activities that have identified significant deficiencies may be partially to blame. However, that is not something that cannot be tweezed out of the statistics OGD provides.

OGD issued only 58 complete response letters (CRLs) in August, which was by far the lowest number issued in any other month in FY 2026. The second lowest month saw 77 CRLs issued with the highest number of CRLs thus far in FY 2026 issued in July (126). There were no refuse-to-receive letters issued in August. OGD acknowledged 39 original new ANDAs in August as their pipeline of new original ANDAs continues on the decline.

OGD approved 114 prior approval supplements in August tied for October 2025 for the lowest number issued in any month thus far in FY 2026. OGD issued 337 information requests, which broken down by 176 for original applications and 161 for supplements. The total number of information requests issued was also the lowest of the FY thus far. In addition, OGD issued 126 discipline review letters in August.

Perhaps August might have been a big vacation month for OGD staff, which could have contributed to the lower number of actions we saw in that month.

OGD reports on its ANDA workload (what we used to call ANDA backlog) by the number of ANDAs pending FDA action as well as anticipated outstanding workload by reporting the number of ANDA awaiting applicant action. The numbers of ANDA awaiting FDA action jumped up a bit to 1184 from 1163 the previous month. The number of ANDAs awaiting applicant action dropped a bit to 1790 from 1841 the previous month. The 1790 number represents 555 outstanding tentative approvals and 1235 CRLs that are in the applicant’s court.

Turning to the receipt side of the data tables, OGD received only 29 new ANDAs in August while not the lowest number in a given month (October had 1 which was a remnant of the government shutdown and February saw only 28 new ANDA submissions). We hope in September we might see an end of FY rush which might boost the numbers. Today if we estimate the full FY’s total of ANDA receipts by using a straight-line average, we can expect to see about 569 ANDA for the full FY. That would be the lowest number of ANDA received by OGD since FY 2015 when only 539 ANDAs were received, and that was because there were 236 ANDA that were refused for receipt based on a significant change in submission requirements.

Also, on the receipt side of the ledger, OGD received 186 amendments to original ANDAs with a breakdown of 42 major amendments, 59 minor amendments, and a whooping 85 unsolicited amendments. Remember unsolicited amendments usually have a negative impact on the review clock and firms are thus somewhat hesitant to submit additional unsolicited information and or data during the current review cycle unless they feel it is absolutely necessary.

OGD also received 1340 supplements in August that represent 1202 changes being effected supplements and 138 prior approval supplements. In addition, OGD received 331 controlled correspondences representing 278 Level 1 and 53 Level 2 submissions.

You can see other additionally reported metrics by viewing the entire August report (here). We will be back with the final FY statistics once the FDA releases the September report.

We continue to express our concern with the fewer number of ANDAs being submitted. As we have discussed in the past, many applicants are adjusting their development spend on complex generics and biosimilars. We are hopeful that as we see additional new company names appearing on the generics approval list, these new firms will begin to fuel ANDA submissions eventually resulting in a boost of the number of ANDAs submitted.