We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three. The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals. Good way to […]
Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months. That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions. Why do […]
With just 6 days until Halloween, what does the prospect for Trick or Treat look like in the ANDA approval candy basket? So far, the reporting of approval actions looks like treats will be in the bag. As of approval actions reported through October 22, 2021 OGD has issued 50 full approval actions and 6 […]
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 […]
According to the unofficial August numbers derived from the FDA’s All Approvals list (here), the Office of Generic Drugs issued 58 full approval (AP) actions and 10 tentative approval (TA) actions during the month of August 2020. The number of APs and TAs are both the lowest number of approval actions in the past 7 […]
With six (6) reporting days left in the month, the FDA’s All Approvals List (here) has identified 43 full ANDA approval actions and 10 tentative approval actions. While this represents a bit slower pace for approval actions, there is still time to meet FY 2020 monthly averages by the end of the month. We want […]
As of August 5, 2020, the FDA had posted 69 full approval actions and 9 tentative approval actions for ANDAs for July 2020. The total of 78 approval actions for the month of July fall short of the 87 Approval actions in June but appears to be consistent with the last four month’s totals. Some […]
Well, there were some hidden tentative approval actions that must have been posted fairly late after June was over as the OGD official numbers released for June show OGD had 14 Tentative Approval (TA) actions (we reported just 5 in our post on July 6 [here]). (However, when looking at the FDA all approvals list […]
Well, June was apparently another good month for the OGD FDA work-from-home teams as the unofficial counts of the numbers show they managed 74 full approval actions and 5 tentative approval actions. The 74 full approval actions represented the highest total in a single month thus far in FY 2020, beating the next highest of […]
OGD approval numbers have surged through June 15th as OGD has already issued 44 full approval actions and 4 tentative approval actions. 14 of those full approvals came on the 15th and 16th of June. Six of those approval actions were for Deferasirox Tablets, 90 mg, a generic of Jadenu. It appears that the block […]
