July, while in the books at least unofficially, got off to a slow start but it picked up towards the middle of the month. I guess the fireworks on July 4th distracted everyone as the burst of colors adorned the skies!
Anyway, during July, the OGD issued 52 full-approval actions and 13 tentative-approval actions for a total of 65 approval actions for the month, which happens to be the lowest total approval actions reported this fiscal year for a single month, but not by much. Of course, the official approval-action totals have only been reported through May 2025 so it’s difficult to say for certain where July will rank this fiscal year. A couple of tentative-approval actions reported were the second tentative approvals issued for the same products. (That is, a tentative-action letter was previously issued but the ANDA sponsor submitted an amendment providing additional information that placed the application back into pending status, and, once the review of the amendment was completed and found acceptable, a second tentative-approval letter was issued.) The OGD reports these second actions in the daily approvals but not in the monthly statistical report. Not that it distorts the approval workload statistics, just want you to be aware of what the designation “Orig2” means in the daily approvals database.
