August was an even better month than we predicted in our post on September 8th (here). There were actually 98 (instead of 96) full approval actions and 12 tentative approval actions for a total of 110 approval actions. The two (2) approvals missed likely were at the end of the month when we first discovered […]
The title of this blog was also the title of the presentation given by Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research. I just could not think of a better title! It is like the State of the Union address but not as expansive. Dr. Corrigan-Curay spoke to the […]
This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]
Today is September 13. 2023. That is not eye-catching news, but the fact that there has only been one ANDA reported as being approved is a bit troubling. We are hoping that this is a recurrence of a glitch in the FDA’s information systems and that ANDA approvals and tentative approvals are just not posting. As […]
We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March […]
Over the Labor Day weekend, the FDA provided the latest full statistical report for the Office of Generic Drugs (here). The news continues to be good on the approvals front as the OGD issued sixty-nine full approval actions (one more than we captured in our unofficial peek (here) as the OGD snuck one by us). […]
On August 25, 2023, the Office of Generic Drugs approved a total of 14 different applications for lisdexamfetamine dimesylate products after the expiration of a patent on August 24, 2023. (This is the first time in a long while where I remember this many applications being approved on a single day.) While this is good […]
Well summertime and its usual vacation schedule has not put a damper on ANDA approval actions and thus, I am happy to report that posting through August 16th reveal that OGD has issued 41 full approval actions and 7 tentative approval actions. If this pace keeps up for the rest of August, this will be […]
Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III. The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do. The changes made to promote transparency […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
