With the official August 2026 numbers reported, let’s take a walk on the wild side and try to predict what the full FY 2026 ANDA approval numbers may look like as we won’t see the full FY 2026 official report on approved ANDAs until sometime in November. Data from the FY 2026 Generic Drugs Program […]
While not yet available in pharmacies, Onswik (insulin efsitora alfa-gobe) injection for subcutaneous use was approved by FDA on September 23, 2026. So, what’s new? This is a once weekly injectable insulin (instructed to be injected on the same day of the week), which according to the Lilly webpage here (and also by my own […]
Just like the new season of Slow Horses premiering in September on Apple TV, it appears that September is also starting out to be a “slow” approvals action month at OGD. With this being midway through the last month of FY 2026, thus far through September 15th, OGD posted only 17 full approval actions and […]
Not the best news (even unofficially), as OGD unofficially issued only 41 full approval actions in August. This represents the lowest monthly number of full approvals in all of FY 2026 to date and with just one month left in this FY, OGD may be scrambling to get more out the door. Although if the […]
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 […]
As a follow-up to our August 5, 2026, post here announcing June 2026 Official Generic Drugs Program Monthly and Quarterly Activities, I promised to provide the mean and median ANDA approval times when OGD updated the Dashboard for June. Well, here is the new chart containing the third quarter for those metrics. The mean and […]
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 […]
