Turkey month has two holidays baked into the calendar and that will likely have some impact on approvals reported this month, especially since the Thanksgiving holiday usually is a super short week, as people take multiple days off! Looking at where the unofficial metrics stand, as of today, the OGD has issued 30 full approval […]
The new 2025 Fiscal Year (FY) looks like it is off to a great beginning with OGD unofficially issuing 61 full approval actions and 22 tentative approval actions for a total of 83 total approval actions. While the numbers look good, it should be noted that the only month in FY 2024 that had more […]
My fingers were tired last night so I did not get to capture a highlight of the presentation made by Dr. Iilun Murphy, Director, Office of Generic Drugs, which is usually one of the biggest draws of this annual conference. So, let’s take a step back and provide you with some tidbits from her presentation. […]
The official August 2024 statistical report was published by the FDA on October 17, 2024 (here). Let’s run through the numbers and then we’ll take a look at the mid-month approvals for October 2024 (the first month of the new Fiscal Year 2025). The official August approvals were a couple below what we had predicted when […]
Well, here we are at the end of Fiscal Year (FY) 2024 and, because we likely will not see official approval action totals for the last two months of the FY until sometime in November, we will take a stab at giving you the best estimate we can. For September, the unofficial approval actions look […]
Some of you have asked why we keep such a close eye on ANDA approval actions. It is a valid question. Knowing the importance of moving freight through the OGD comes from a combined 40+ years of experience, both in the OGD and in industry, and it is clear to me that this is the […]
At least unofficially, it appears the August 2024 approval numbers for ANDAs have popped back up. As of the posting on the Daily approval listing (here) and the All approvals listing (here), there were 67 full approval actions, the second highest of Fiscal Year (FY) 2024 thus far, and 15 tentative approval actions. We will […]
Just 25 days before the end of Fiscal Year (FY) 2024, the official July statistics were just posted here. The two biggest items of interest to industry from these monthly reports are usually the number of approval actions, as well as the number of ANDA receipts so, let’s get the important stuff out of the […]
The FDA keeps track of first generic drug approvals for each calendar year and just posted the number for the first six months of calendar year 2024 here. Be aware that the OGD also posts first approvals in its Generic Drugs Program Monthly and Quarterly Activities Report (here) but the first approvals posted on this […]
The official numbers for June 2024 are in and posted on the FDA’s website here. The OGD issued fifty final full approvals along with fifteen tentative approvals in June. Of the fifty approvals, four were first time generic approvals and nine (18%) were first-cycle approvals. Of the fifteen tentative approvals, there were no first-cycle approvals. […]
