Even though it is February 21, 2025, we are only reporting ANDA approval actions posted through February 14, 2025, because approval actions have been slow to post on the daily approvals listing on the FDA web site, possibly impacted by the pause in the FDA communications imposed by the new administration.
Thus far, through February 17, 2025, the OGD has issued 27 full-approval actions and 9 tentative- approval actions which is about average for one half of a month. We will provide further details once we believe the full figures are in for February.
It should be noted that the last Generic Drugs Program Monthly and Quarterly Activities Report was issued in November 2024, and we are thus only one week shy of three months of seeing the December report, which will also have approval time metrics for the first quarter of FY 2025. The lag time in issuing the monthly report is a bit more than we have previously experienced. Force reduction could be contributing to the slowdown in issuing approval actions and various reports, but it is too early to make any real predictions on the cause.
