Thus far, the Office of Generic Drugs (OGD) has issued a total of 32 full-approval actions and 7 tentative-approval actions for a total of 39 approval actions through March 21st. Unless there is considerable upward action on approvals through the end of the month, it is likely that March will be the lowest month for approval actions so far this fiscal year (the OGD has not yet issued final official figures for February 2024, but our unofficial numbers for that month were 52 full and 11 tentative approval actions).
By taking a daily average of the March activity to date, it is estimated that there will be 45 full-approval actions and 10 tentative-approval actions. The previous lowest number of full approvals came in November 2023 with 51, and lowest number of tentative approvals came in December 2023 with 11.
The highest total of approval actions this fiscal year came in January 2024 when the OGD issued 56 full and 17 tentative approval actions. Last fiscal year, the two big months were March 2023, when there were 96 full and 21 tentative approval actions, and August 2023, when the OGD issued 98 full and 10 tentative approval actions. The FY 2023 monthly average for full approvals was just a tad over 65, and for tentative approvals it was 14.3. It will likely be significantly lower this fiscal year unless things change dramatically.
Not sure why this fiscal year is looking down. If you have any ideas, please let me know at r.pollock@lachmanconsultans.com; also let me know whether I can share these thoughts, but they will be nonattributable to you.
