We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March 2023. Also, it ties the full-approval actions from March at ninety-six.

The number of unofficial approvals in August beat the ten-month official approvals average (through July) of sixty-four by thirty-two, and this will have an impact on the total number of approvals for FY 2023. This is good news for the OGD as we are seeing fewer ANDAs being submitted this year (ten-month average of 60.3), which will likely mean that the OGD will approve more ANDAs than it receives by the end of the FY.

We will address the lower number of ANDA submissions after the official report for September is posted. There is always a chance for a large number of ANDA submissions in the last month of the FY, especially since the announced GDUFA fees for FY 2024 are significantly higher than those for FY 2023.

Once the official numbers are posted for August 2023, we will be back at our prognostications for the full FY.