This morning, I was perusing the agenda for the upcoming GRx-Biosims 2026 conference and was reviewing the list of speakers when I noticed that Darby Kozak, Ph.D., was listed as the Acting Director of OGD. I searched the FDA’s OGD webpage, and lo and behold Dr. Iilun Murphy was still listed as the OGD Director. […]
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 […]
CDER published a study titled “First-Cycle Complete Response Rates for CDER NDA and BLA Applications” (here). I read and reread it a few times and I am still confused. It appears that FDA published this report to counter industry’s stated belief that the number of Complete Response Letters (CR) have increased over time. This is […]
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 […]
The AAM 2026 Savings Report, developed in partnership with IQVIA, was released yesterday (here) which describes the tremendous savings that the American consumer has realized from generic drug products and biosimilars. With generics accounting for 89% of all prescriptions dispensed and the uptake of biosimilars increasing, the savings are sure to compound. The facts speak […]
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 […]
In November 2025 the FDA requested that manufacturers of hormonal treatments for menopausal symptoms make changes to the labeling to remove boxed warnings about a probable risk of breast cancer, cardiovascular disease, and probable dementia because new information evaluated by the Agency has made those warnings obsolete. These changes in labeling have had a dramatic […]
In an article published today on FDA’s webpage (here), the FDA notes that it “is aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients”. The problem has been identified as the use of a dietary grade of glutathione […]
