Well, it looks like the FY 2025 ANDA approval numbers are posted on the FDA full approval page but not yet in the official Generic Drugs Program Monthly and Quarterly Activities Report. Now, we may miss a couple here and there because the postings are sometimes slow, but I think this will give us a good look at where the OGD falls in terms of full approval and tentative approvals for FY 2025.
The unofficial numbers thus far for September suggest that the OGD will fully approve 39 new ANDAs and issue 15 tentative-approval actions. The August numbers that are still unofficial, which we reported here, are 47 full approvals and 14 tentative approvals, with two being second tentative approvals for the same product. Not to confuse the situation but the OGD has not yet published official approval totals for August or September 2025; thus, we have only unofficial totals for these two months.
If the September total of 39 full approvals becomes official, it will represent lowest number of full approvals in any month in FY 2025. August’s unofficial full approvals of 47 would be the second lowest of FY 2025. Completing the trifecta of low-performing months is July with its full approvals of 52 being the third lowest for the fiscal year, which, you guessed it, means that the number of full-approval actions has fallen to its lowest level for three months in a row.
Now, if we accept the unofficial totals of approvals for August and September, then the number of fully approved ANDAs in FY 2025 will be 688, representing the lowest number in a given fiscal year since FY 2021 when the OGD approved 679 original ANDAs.
While the last three years have seen declining ANDA approval numbers, I’m not sure we are seeing a definitive trend over the last five years. The number of approvals does not seem to be improving, however, given the new incentives introduced in the GDUFA III program, which is in effect from October 1, 2022 through September 30, 2027.
Unfortunately, we don’t have a window into the number of new ANDAs submitted to the OGD for August or September, but for the first ten months of FY 2025 there have been only 448 new ANDAs submitted. As soon as the OGD updates its full FY 2025 official statistics, we will be back with some additional commentary. Those of you who regularly read our blog know the concern we have expressed regarding the decline in new ANDA submissions, especially over the past three years.
The new FY 2026 UFA fees began on October 1, 2025 but, with the government shutdown, the FDA cannot accept any new fee-paying applications until the federal government reopens. This will likely place an additional strain on OGD staff if the shutdown runs longer than a week or two. Hopefully the existing UFA carryover funds will last to keep the FDA operating until new funding is in place.
