The OGD’s approval actions for the month (at least those posted by March 5, 2024) are in line with the first four months of this fiscal year. There were 52 full approval actions and 11 tentative approval actions for a total of 63 approval actions. While we have not seen January’s official statistics yet, the average for full approval actions for the first three was 53.6, and for tentative approval actions an average of 14.7.
Remembering that February is a short month, which also contains one federal holiday, it is not a bad showing. We are hoping to see more throughput in the coming months to boost the full approval numbers as they are lagging well behind the FY 2023 monthly full approval action average of 65.2. If the OGD continues on this current trajectory, there will likely be about 140 fewer ANDAs approved in FY 2024. The unofficial January numbers (reported here) showed 55 full approval actions and 19 tentative approval actions, so that would not likely raise the yearly total of full approvals, but the tentative approval actions would be the highest number per month in FY 2024 thus far.
