While we were able to piece together the April 2025 unofficial approval picture, we need to note that it has now been over three months since any official statistics from the Generic Drugs Program Monthly and Quarterly Activities Report have been published publicly (see here). This is a bit discouraging, but not totally unexpected, after the OGD staffing cuts since February 2025. This means that we haven’t seen any official statistics for the full second quarter, which ended in March, and would contain both mean and median approval times for ANDAs, along with the usual set of monthly statistics, all of which are important values for the generics industry.
Getting back to the April approval-action numbers, it looks like the OGD issued 62 full-approval actions and 8 tentative-approval actions, for a total of 70. (This was last checked by me on May 7, 2025 so the numbers should include most, if not all, of the approval actions.) Regarding the full approval actions, 35 were issued in the first fifteen days of April and 27 were issued in the last fifteen days. I separated the first and second halves of the month to try to see whether there was a difference as time ticked by after the layoffs at the OGD. I was expecting the end of the month to have had fewer, partially because the queue for approvals might have still been top loaded in the first half of the month; however, the difference is more likely random. I say this because the first three days of reported approvals in May totaled 17 full- and 3 tentative-approval actions (20 already) so I believe that this likely disproves my assumption.
So, at least at this point, it appears that the OGD is focusing on moving the freight through the approval system, while other areas (i.e., reporting and updating the official statistics) may be taking a back seat. We will keep an eye on trends in reporting and output over the next few months as the dust from the layoff “storm” continues to settle.
