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 one metric, above all else, that projects to the industry how well the OGD is doing. While that might not be fair, it is a reality of the generic business. Approvals are the lifeblood of the industry. We all know that the OGD and OPQ do much more than just approve ANDAs, but it is the number of approvals that really sets the standard for the industry’s perception of how the system is working.
So, here we are, about twelve days from the end of FY 2024. We’re coming to the finish line, and we must wait for the official numbers from the Agency; the numbers will likely not be available until sometime around Thanksgiving. Thus, a look at where we are, is, in a sense, an important metric when looking ahead. Thus far through September 16th, the OGD has issued twenty-nine final-approval actions and just five tentative-approval actions.
So far, it looks like we can expect an average number of approval actions by the end of the month unless there’s unusually high activity in the latter half. After the first week in October, we’ll take an unofficial look at the full fiscal year’s total approval actions and match that up with the official numbers when they are released. Remember, the official actions have not yet been released for August 2024 so we may have to go further out on a limb when we make those predictions! Speak to you about that then!
