As of August 5, 2020, the FDA had posted 69 full approval actions and 9 tentative approval actions for ANDAs for July 2020. The total of 78 approval actions for the month of July fall short of the 87 Approval actions in June but appears to be consistent with the last four month’s totals. Some higher, some a bit lower. We await the official counts that should be released sometime in the next couple of weeks.
Remember last month only 6 of the 14 tentative approval (TA) actions was posted on the All Approvals and Tentative Approvals page here prior to the publication of the official number in the Generic Drugs Program Activities Report – Monthly Performance (here) and as of today, the All Approvals list still only has 6 TAs listed for ANDAs. Thus, there may be more TAs than we are able to identify for the current data.
We will report on the official July numbers along with the release of new ANDA submission and complete response letters issued as soon as they are published and will provide full FY updated estimates of approval actions and new ANDA submissions at that time.
