We now have official statistics for one-third of FY 2026. While the number of full approvals hit a high (by one) for FY 2026, the number of new ANDA receipts in January were disappointing. Let’s take a look at the most significant statistical metrics for the current report.
As far as FDA actions, the OGD fully approved 59 ANDAs in January, and, of those 59, 6 were for first-time generics and 17 (28.8%) were first-cycle approvals. Of the full approvals, 13 were generated as imminent actions where the goal date was extended so the OGD could take an approval action. There were also 19 tentative approvals, of which 5 (26%) were first-cycle approvals and 4 were tentatively approved through the imminent action program. So, all together, the OGD took a total of 78 approval actions in January, ranking this month second of the four months reported to date for FY 2026.
The OGD hit a high for complete response letters (CRLs) this fiscal year with 124 being issued. This is significantly higher than any other month this fiscal year. There were 2 refuse-to-receive actions issued as well. The OGD issued 64 acknowledgement letters for new ANDAs.
The OGD approved 136 prior approval supplements (PASs) and issued 414 information requests (the lowest number thus far this fiscal year), broken down as 208 for original ANDAs and 206 for supplements to approved ANDAs. There were also 154 discipline review letters issued in January.
As far as a measure of ANDA workload, the OGD reports that there were 1,265 ANDAs pending FDA action, down from 1,326 the previous month, and 1,872 ANDAs awaiting applicant action, up slightly from 1,845 in December. The breakdown for applications awaiting applicant action is 581 tentative approvals and 1,291 outstanding CRLs.
On the receipt side of the house, the number of new ANDAs received was only 32, and this is clearly an ominous piece of news. With one-third of the fiscal year in the books, if the submission rate remains the same, the OGD would likely only receive 522 new ANDAs in FY 2026, down from 600 in FY 2025 and 740 in FY 2024. The steep decline is obviously worrisome.
There were 168 amendments submitted to the OGD in January, which is in line with previous months’ ups and downs. The breakdown by type is 46 major, 65 minor, and 57 unsolicited amendments.
Supplements hit a high for FY 2026 with 933 being submitted. Of those, 813 were for changes being effected (CBE) supplements and 120 were for PASs, while controlled correspondences dropped to 267 from 361 last month.
Well, that gives you something to chew on as the year continues. You can view all of the official January monthly statistics here. Let me know if you have any questions or comments on the stats!
