The end of the FY saw a bump back up to the 80’s for number of total approvals with 73 “line item” full approval actions and 10 tentative approval actions. What the heck is a “line item” approval action, you may ask? Well, we noticed in September (or perhaps we just missed it in previous months) that OGD reported single “line item” approvals for multiple strengths within a single ANDA and listed them separately in the daily approvals list (see snip for example below).
We are not sure how OGD will report these line items on the Generic Drugs Program Activities Report – Monthly Performance, although we have been told that they will appear as a single approval in the monthly count. The count for full approval actions would then decrease by 3 from the individual approval actions list, as this multiple line item listing also occurred for one other ANDA during the month. Thus, we would expect the official total to be 70 full approval actions and 10 tentative approval actions. We will see when OGD posts the official counts in a week or two.
Nonetheless, OGD had a total of at least 80 (70 + 10) approval actions in September. In addition, we have been surprised by a larger number of TAs in the official number of tentative approval actions over what appears in the daily report in the last few month, so the total approval actions may actually increase when the official numbers are released. We can’t get an answer from FDA on the difference seen in these two documents, which can sometimes be significant.
The highest number of approval actions so far this FY came in April and June with each month reporting 87. If there are a number of “hidden” TA actions, then maybe September has a chance to be the leader of the FY! Once the official numbers are in, we will provide the FY 2020 totals for your viewing pleasure!