The OGD is off to a good start in 2025, with 31 full-approval actions and 14 tentative-approval actions for a total of 45 approval actions posted as of January 16. While this number is not as high as the number of Executive Orders signed by Trump in his first day back in office, if the pace keeps up, we might even see another month with 80+ approval actions (note that October had 82 total official approval actions and December, as we reported unofficially, had 84).
January is an odd month as it has a couple of holidays, but with the inauguration falling on the same day as Martin Luther King Day, our friends at the FDA only had two, rather than three, days off. Could it be that, with the dwindling number of original ANDAs being submitted in the first two months of FY 2025 (14 and 18, respectively), there is more time to concentrate on approvals?
Well, whatever the reason, it’s good to see that approvals may be getting back on pace.