First Month of FY 2020, October Approval Numbers Look Like Tail of 2019

I am pleased to report that the approval and tentative approval actions are again appearing on the daily approvals and All Approvals listing on the FDA website again.  So far, it looks like another of the slower months for approval and tentative approval actions to start off the new fiscal year.  To date (through October 30), the OGD ANDA approval actions for the month are reported at 52 full approval and 9 tentative approval actions.  This is obviously the unofficial numbers and does not include any approvals not yet reported on October 31.

Note that this is a preliminary view of October approval actions.  Official numbers will be out in about 7-10 days.  Just as a reminder, OGD started off FY 2019 with 110 full approval actions and 22 tentative approval actions.  The lows for FY 2019 were 45 approval actions in June and 9 tentative approval actions in September.   With many older applications having undergone 2 or more review cycles, it is surprising that the numbers are not higher (even though OGD broke the approval record for FY 2019).  Is it something industry is doing? Is there something that companies need to correct?  Perhaps we will hear a perspective on the apparent monthly trend towards lower approval numbers at the Association for Accessible Medicines GRx+Biosims meeting next week.  I will keep you posted!