As of postings today on the Recent New and Generic Approvals site (here), the Office of Generic Drugs (OGD) has issued 58 full approval actions and 12 tentative approval actions for a total of 70 actions in November 2024. In our unofficial count for October 2024 reported in our blog post here, we reported that the OGD had unofficially issued 61 full and 22 tentative approval actions totaling 83 actions. This number is not too different for the full approval actions between the first two months of Fiscal Year (FY) 2025, but more activity is seen for tentative approvals in October. Given the month-to-month variations that are typical for the ANDA approval metrics, this is not surprising. We do note, however, that no official approval numbers have yet been posted for the first two months of the new Fiscal Year 2025, so these numbers could change a bit due to late postings by the OGD.
There is a bit of a unique issue with relying on the number of tentative approvals as an accurate measure of future final approval, because while each tentative approval could likely lead to full approvals at some point in the future, they are not a great predictor of the OGD’s final approval actions for a specific month (or even FY) given that many tentative approvals (which are termed tentative due to being blocked by periods of patent or exclusivity) could take months or even years prior to showing up as a fully approved ANDA. While tentative approvals are an important output metric for the OGD, we must remember that, once fully approved, it is counted as only one final approved ANDA. Thus, I like to think of the reporting of full approvals more as the ultimate measure of the OGD program’s success.
Having said that, and with the caveat that we are looking at only 2 months of unofficial data (with 61 full approvals for October and 58 for November), if this trend continues throughout the FY, we would likely be looking at a total of 714 full approvals in FY 2025 compared to FY 2024 official ANDA approvals of 694. And yes, although I realize it is too early to draw any conclusions, it is still an encouraging sign.
