While the charts on the Generic Drugs Program Monthly and Quarterly Activities Dashboard (here) have not yet been updated, the final statistics for FY 2026 are on the Submissions Data Table which is in the form of an Excel spreadsheet. It is not very easy to read but all the data is there.

First let’s run down the reported September 2026 metrics along with the full FY 2026 metrics. OGD fully approved 50 ANDAs in September bringing the full year total to 700 ANDA approved (we missed by one in our estimate of 699 from an unofficial post). Of the 50 approved in the last month of FY 2026, 3 were first time approvals, 13 (26%) were first cycle approvals and 4 were approved under the imminent action program. Of the 700 ANDAs in the FY, 137 (19.6%) were approved in the first cycle. OGD also tentatively approved 12 ANDAs of which 1 (8%) were approved in the first cycle. For the full year OGD issued 253 tentative approvals.

There were 87 complete response letters (CRLs) issued in September, and for the full FY, OGD issued 1094 CRLs for a FY 2026 monthly average of 91.2. During the entire FY OGD only issued 11 refuse-to receive letters. This is an all-time low for any FY in the age of GDUFA. The agency acknowledged 39 new ANDAs and for the year acknowledged 607 ANDAs. OGD approved 127 prior approval supplements in September with a FY total of 1579 (monthly average of 131.6). OGD also issued 452 information requests in September and 5,181 for the full FY, this is broken down by 2,735 issued for original ANDAs and 2,446 for supplements. Discipline review letters (DRLs) issued totaled 210 for September and 1,985 for the full FY.

As for the end of year “backlog” figures, OGD reports there were 1220 ANDAs awaiting FDA action, about 48 higher than the previous month, but that was due in part to the number of new ANDA submission in September (see below for the big number!). The number of ANDAs awaiting applicant response was 1,786 of which 554 were due to outstanding tentative approval actions, and 1,231 were CRLs awaiting applicant response.

OGD received 116 new ANDAs in September, the highest number in any month in FY 2026. The total of new original ANDAs received for the full FY was 638. While the total was 5% better than FY 2025.

The table above shows a disturbing overall downward trend in the number of new ANDAs submitted over the last 5 FYs. Gone are the big submission years like FY 2018 with 1044 new ANDA submissions, FY 2017 with 1306 and FY 2014 with 1473. Factors that may have influenced the decreased number of ANDA submissions include industry consolidation, movement to more selective higher value complex generics, razor thin margins on many generics, movement of larger generic companies into the more lucrative biosimilars space just to name a few.

Other incoming submissions included September’s receipts of 145 amendments which are comprised of 49 major, 54 minor and 42 unsolicited amendments. OGD received a FY total of 2,020 amendments (628 major, 658 minor and 734 unsolicited amendments). Another metric big-ticket item is the number of supplements OGD receives. In September, OGD received 974 (841 of which were CBEs and 133 PASs). The total number of supplements for FY 2026 was 12,129 of which 10,372 were CBEs and 1,757 were PASs.

There were 3,835 controlled correspondences received by OGD during the FY, 326 of them in September.

This was an interesting year and with negotiations completed for GDUFA IV we will report on some of the changes you may see, but for now if you want to see more of the raw monthly and total FY 2026 stats just click here and scroll down to the Download Monthly and Quarterly Activities Dataset button. As noted above the entire dashboard has not yet been updated, so we have not seen any data on the last quarter for mean and median approval times for new ANDA and tentative approvals. Once those become available we will provide you with the results.