We’ve been waiting for the first Generic Drugs Program Monthly and Quarterly Activities Report to be published for FY 2026, and it arrived sooner than expected! There’s at least one surprise and there are a few other interesting observations that we will discuss regarding new ANDA submissions for October 2025. But first, let’s talk about approvals.

The OGD issued 54 full approvals (we hit that nail on the head in our unofficial stat post here) but we missed on the tentative approvals by two as the OGD actually officially issued 21 (we had unofficially reported 19). Of the 54 full approvals, 5 were for first-time generics and 15 (27.8%) were first-cycle approvals. Having first-cycle approvals hit 27.8% is a nice start for the first month of the new fiscal year. Also, 11 of the full approvals were the results of imminent actions that delayed the GDUFA goal dates. Of the 19 tentative approval actions, 2 (10.5%) were completed in the first cycle.

There were 98 Complete Response Letters (CRLs) issued in October along with 55 new ANDAs acknowledged. The OGD approved 114 Prior Approval Supplements (PASs), which is close to the FY 2025 monthly average of 124. The OGD issued 465 information requests (broken down as 266 for original ANDAs and 228 for supplements) as compared to the FY 2025 monthly average of 446. Discipline review letters issued totaled 172 compared to the FY 2025 monthly average of 162.

Workload for the OGD is reported by applications awaiting FDA action and applications awaiting applicant action (from tentative approvals (TAs) and CRLs). FDA inhouse applications stood at 1,300 (a decrease of 21 since September 2025). Applications awaiting sponsor action stayed about the same at 1,880, broken down as 566 awaiting responses from TAs and 1,305 awaiting sponsor responses to CRLs.

There was one refuse-to-file action taken by the OGD. And, for the first time ever, there was only one ANDA received by the OGD during the month. Could these two things be related? Now, knowing that the OGD was prohibited from accepting any fee-paying application submitted after September 30, 2025 until the government shutdown was over in mid-November, there should be, as one might think, zero applications received by the OGD in October. Well, there are only four plausible explanations:

    1. It was an error (highly unlikely).
    2. The one application that was received was the one refuse-to-receive application (again unlikely, but possible).
    3. The sponsor had the foresight to pay its GDUFA fee prior to October 1, 2025 and the application was sent after September 30, 2025.
    4. The one application submitted was for a PET drug as these are non-fee-paying applications and would not be precluded from submission.

We’ll let you know once we can confirm which of these four possibilities is correct!

As far as notable receipts, there were 161 amendments (52 major, 50 minor, and 59 unsolicited) received by the OGD in October. This is a tad below the FY 2025 monthly average of 174. Supplemental submissions fell below the FY 2025 monthly average of 976 by about 100 to 875 (broken down as 727 CBEs and 148 PASs). Controlled correspondence submissions fell below the 300-level to 263.

All in all, with the exception of new ANDA submissions, the OGD was not far off from monthly averages of the past fiscal year. Clearly, we’ll see the impact of staff layoffs, retirements, resignations, and rehirings during the shutdown (as well as those that occurred during the past year) over the next few months as we keep a close eye on OGD statistics. We do expect to see a large number of new ANDA submissions reported in November as they will represent all of the ANDAs that could not be submitted in October as well as all of the November submissions.