Well, we are halfway through June and it’s time to take a look at the unofficial Approval Actions. Through June 17, 2025 (note that the OGD is usually a day or two behind on approval postings), there were 29 full-approval actions and 12 tentative-approval actions posted on Drugs@FDA: FDA-Approved Drugs (here). What this means is, thus far this month, the OGD has issued a total of 41 approval actions. Even with a holiday week coinciding with the last week in June, if this pace keeps up, the OGD will have a pretty good month.
With several of the policy staff being brought back to the OGD after being laid off, some of the more difficult ANDAs to move through the system, due to either scientific or regulatory complexity, may also start showing up in the approvals column. I’m a bit surprised at the flow of ANDA approvals coming out of the OGD with all of the disruption caused by the layoffs, but the OGD seems to be handling things well with reduced staff. Kudos to them!
