At least unofficially, it appears the August 2024 approval numbers for ANDAs have popped back up. As of the posting on the Daily approval listing (here) and the All approvals listing (here), there were 67 full approval actions, the second highest of Fiscal Year (FY) 2024 thus far, and 15 tentative approval actions.
We will wait until the official FY statistics are in before we start making final comments about the full FY statistics, but even if we get a good number of approvals in September, we will likely end the FY with somewhere between 680-700 new ANDA approvals, which unfortunately will still be well below the total number of 782 full approvals from last FY year. However, we won’t see the final official approval numbers until perhaps the end of November 2024, the second month of FY 2025.
