Unofficial October 2026 ANDA Approval Actions and More on FY 2026

The first month of the new FY was (unfortunately) a slow start out of the gate. While not the lowest month we have seen over the past year, it is certainly at the lower end of approval actions.

In October, OGD issued 43 full approval actions and 8 tentative approval actions. It was interesting that at the GRx+Biosims meeting, Darby Kozak, Ph.D., Director, Office of Generic Drugs, gave an update on the OGD FY 2026 performance metrics and never broke out the full approvals for the full FY or mentioned any reason that the approvals output for OGD has plateaued over the past three years. While there were a couple of big months for full approvals in FY 2026 (for instance April saw 86, June saw 77 and July saw 68), these came in months when there were large numbers of NCE-1 approvals. However, most months were in the 40s or low 50s. Perhaps the staffing level at OGD has reached a point of a steady state of approval output over the past 3 years. To give you some additional perspective, below is a chart with the total number of full ANDA approvals and the monthly average for each FY for all the years OGD has been operating under the GDUFA program.

*Note that the official statistics for FY 2026 have not yet been published as of 11/5/2026 so we have included 49 unofficial September approval numbers we have gathered from the FDA daily posting for the month of September.

The beginning years of GDUFA were clearly learning years for both FDA and industry. After that bumpy start, the approvals started to rise. The overall average over the first 14 months of GDUFA is 676.6 ANDA approvals/month. Clearly, there are some down years but with increasing staff and decreasing numbers of ANDA submissions, one might think that approvals would be on an upward trend again. There are other factors to consider that may play a role in this trend, including that over the last decade, there have been more and more requirements for submissions, which means more data for FDA to review. We can’t also forget about the DOGE cuts and subsequent blows to employee morale and any disruptions that might have caused. However, these approval numbers are all well beyond the first three years of GDUFA as FDA and its stakeholders got used to new programmatic expectations. We expect there will be ups and downs, but for us outside of the Agency, we don’t have full transparency regarding the factors that may influence numbers seen in the down years and can only guess as to their cause.