August was the slowest month for approval actions in FY 2025 and, now that we’re in September, let’s hope that this will not become a trend. The OGD issued 47 full-approval actions, the lowest of this fiscal year, with February the second lowest at 53. As far as tentative-approval actions, the OGD issued 14, also the lowest number in any month thus far this fiscal year. However, four of these were the second tentative approval letters issued for the same product and should decrease the number of tentative approvals by four when the OGD issues the official approval numbers in the Generic Drugs Program Monthly and Quarterly Activities Report that includes the August 2025 data.
We’ll keep close track of the approval numbers and report them as they become available. The next few months could be very telling.
