The official November 2025 OGD statistics are in the books and, as far as approvals are concerned, the OGD had a good month with 58 full approvals and 26 tentative approvals reported. Of the 58 full approvals, 6 were for first-time generics; however, only 6 (10%) were first-cycle approvals. This is one of the lowest percentages of first-cycle approvals that we’ve seen within a month in a very long time, and it is also a metric that the OGD has said that it hopes to improve. So, what is going on? Is this a one-off month? Of the 26 tentative approvals, 6 (23%) were first-cycle approvals. The OGD has not been able to get over the 25% first-cycle approval rate on a consistent basis. So, let’s hope that November is a one-off month for original ANDA first-cycle approvals.

The OGD issued 92 complete response letters (CRLs) in November. While FY 2025’s average was about 107, the number of CRLs issued these last four calendar months (which includes this November) have been 82, 88, 98, and 92, respectively. Hopefully, this trend will improve over the next few months. In November, the OGD refused-to-receive 2 ANDAs and acknowledged 51 new ANDAs.

The work on prior approval supplements (PASs) continues at a good clip with 122 approvals posted in November. The OGD has approved over 100 PASs each month for the last calendar year except for November 2024 when it approved only 86. The high for the previous twelve months was achieved in October 2025 when the OGD approved 160. The FY 2025 monthly average was 124.

Information requests (IRs) have been on the high side in the first two months of FY 2026 with 494 and 473 reported for October and November, respectively. The FY 2025 monthly average was 446. The 473 IRs issued in November were broken down as follows: 178 originals and 295 supplements. Discipline review (DRs) letters dropped from 172 in October to 119 in November. The FY 2025 monthly average was 162. It is unclear what the cause is for the large drop off.

The OGD reports its ANDA workload in part by listing the number of ANDAs awaiting FDA action and the number awaiting applicant action. The number of ANDAs awaiting FDA action dropped from 1,300 in October to 1,272 in November. The number of ANDAs awaiting applicant action dropped by 9 from last month to 1,871. The 1,871 represents 585 outstanding tentative approvals and 1,286 CRLs sitting with applicants awaiting their response. What we do know is that applications awaiting FDA action are part of the work that the OGD still has to complete. What we don’t know is how many of the outstanding tentatively approved ANDAs or ANDAs with complete responses outstanding will eventually be pursued by industry. While the OGD does send dunning letters to ANDA applicants with CRLs without response for over one year, I do not believe that it routinely does so with tentatively approved ANDAs.

On the receipt side of the house, we have may have reason for concern. As you likely remember, in the first month of FY 2026, October 2025, the OGD received only one new ANDA because it could not receive any fee-paying applications during the government shutdown. According to the FDA, the one ANDA that was received was actually submitted in September, prior to the shutdown, and somehow was reported as being submitted in October. The shutdown was not over until mid-November and that was when the OGD began receiving ANDAs again. The total number of ANDAs submitted in November was reported as 46. We expected that number to be significantly higher, given the fact that no ANDAs were received for a month and a half during the shutdown. We were proved wrong (at least we think we were wrong!). What we don’t know is whether the OGD reported all of the ANDAs received in November or just the ones that it was able to review for completeness and acceptability even though the annotation on the report states that original receipts are reported as raw receipts (versus filed receipts). If the OGD reported all of the ANDAs it received, then for the first two months of FY 2026, the total number of new ANDAs is 47, or a monthly average of 23.5 ANDAs per month. We hope to see a significant improvement in the coming months or the FY 2026 total of ANDAs submitted will fall well below the 600 received in FY 2025. This 600-number was the lowest submitted since GDUFA began except for FY 2015 when 539 ANDAs were received by the OGD; this low number was caused by a change in the OGD stability policy associated with 236 ANDAs that were issued refuse-to-receive letters as a result of not complying with the new policy.

The OGD received 198 amendments in November with 60 being classified as major, 48 as minor, and 90 as unsolicited amendments. The number of unsolicited amendments is on the high side, although there are usually two to three months each fiscal year with a high number of outliers to this metric.

As far as supplemental submissions go, the OGD received only 768 supplements (639 changes being effected and 129 PASs) in November, the lowest since January 2023 when 688 were submitted. The FY 2025 monthly average for supplements was 976.

The OGD received 234 controlled correspondences (CCs) in November, representing another drop in submissions compared to the FY 2025 monthly average of 326 CCs.

With submissions of new ANDAs, supplements, and controlled correspondences down across the board, there is continued worry about the sustainability of the generic workload and its impact on staffing levels at the OGD. Let’s hope that industry picks up the pace of submissions as the new fiscal year progresses. While we have discussed many of the statistics of higher interest, you can access the full November 2025 statistical report here.