February was a short month with a big number as the OGD issued 64 full-approval actions and 25 tentative-approval actions for a total of 89 approval actions. This represents both the highest number of approvals thus far this fiscal year and the most total approval actions since January 2025, when there were 90.
With ANDA submissions down, is it possible that the OGD now has more time to concentrate on getting approvals out? The number of first-cycle approvals has not increased over the past year, however, so maybe now the FDA has more time to look at second- and third-cycle complete response letter amendments and get those approvals moved through process faster. We’ll see what February’s first-cycle approvals look like when the OGD issues its official statistical report for the month. Anyway, kudos to the OGD for a great February from an approval standpoint!
