We are coming up to the end of another Fiscal Year and the OGD has just 2 months of official stats to report. Here is what Happened in July. OGD approved 68 new ANDAs and issued 18 tentative approval actions in July. Of the 68 newly approved ANDAs, 6 were for first-time generics and 11 […]
August has brought a lot of heat over most of the US. So far this month, the descriptor of “hot” does not appear to apply to the pace of ANDA approval actions. Maybe the review folks from FDA are escaping the heat on vacation but through August 15th, OGD has posted only twenty ANDA approval […]
The Official Generic Drug Monthly Statistical report has issued (here) and is in a new format. As of this morning (August 5), the charts for the June data have not been updated; however, if you scroll down to the “Download Monthly and Quarterly Activities Dataset” button you can find the data metrics for June. Let’s […]
With the World Cup now behind us and Spain crowned the new champion of the soccer world, it is time to get back to business as usual! The first half of July saw the Office of Generic Drugs issue 28 full approval actions and 3 tentative approvals for a total of 31 approval actions for […]
June was a hot month for most of the East Coast, and it was a hot month for ANDA approval actions too (albeit but just a tad cooler than May’s numbers). OGD managed to issue 76 full approval actions and 17 tentative approval actions for a total of 93 approval actions in June. The 76 […]
The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they […]
Here we are, in the middle of June already! Where does the time go? If you have a few minutes away from scanning the World Cup results, let’s see how the OGD is doing, as far as approvals go, during the first fifteen days of the month. As of June 15th, the OGD has issued […]
As we noted in the May mid-month blog report (here), the May approval action total was likely to be much lower than April’s high for the fiscal year of 85 full and 19 tentative approval actions. Well, May’s numbers are indeed lower, and by quite a bit. The unofficial peek at the monthly figures in […]
Through May 15, 2026, the OGD reports 26 full approval actions and 11 tentative approval actions. Given the number of actions in the first half of the month, May approval actions will likely fall well behind the April figures, even if the approval pace picks up. So, with 37 total approval actions thus far in May, […]
We previously noted that April would likely be a good month for OGD approvals, and it was! The OGD approved 85 ANDAs, of which 41were first-time generics; however, only 10 (11.7%) were first-cycle approvals. This low percentage of first-cycle approvals is likely because of the large number of single-entity and combination dapagliflozin products that were approved […]
