Preliminary January Counts of Approval Actions

As of February 4, 2020, there have been 49 full approval actions and 13 tentative approval actions posted for January 2020.  As always noted, these number come from the available data on FDA’s All Approvals site (here) and FDA’s Recent New and Generic Drug Approvals list which is updated daily (here).  The official numbers will likely be posted in about 2-3 weeks and we will revise them when we can, along with the number of new ANDA submissions and complete response letters.

If the number reported holds for January, at 62, it will be the lowest number of total (full and tentative) approval actions so far this FY, with the next lowest at 65 in October 2019, the first month of FY 2020.