The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number. The OGD also acknowledged sixty‑two ANDAs in March. Other metrics […]
If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen! […]
According to the Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance published yesterday, the Office of Generic Drugs is looking at over 1,712 ANDAs that are pending Agency action. While down a bit from the 1,749 reported at the end of the first quarter, the number jumped from the end of […]
The OGD updated its usual February statistical report late yesterday (April 18, 2022) to complete the month’s reporting. To start out with a bit of a startling number, February saw nine ANDAs issued refuse‑to‑receive (RTR) letters. This is triple the number in any month this FY (only three RTRs were reported in each of the […]
We were close with our estimates for February approval actions, but the FDA reported one fewer full-approval action than we did (fifty-nine vs. sixty) and, upon review, note that it was because one of the ANDAs was listed in a separate line item as an action. Sorry we missed that! Of the fifty-nine full-approval actions, […]
Late Wednesday afternoon, the FDA posted official metrics for the items mentioned above. This was a p quick turnaround for these figures as they usually come out about the middle of the month. The OGD report (here) lists 61 full approval actions (we missed on our predictions by 1), which included 7 first generic approvals, […]
January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days. Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]
The Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the first quarter of FY 2022 (here) has both good news and bad news. The proverbial question is, which one do you want first? At this juncture, I might also point out that some of the data is also difficult to […]
We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions. We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two. Thus, the total number of approval actions […]
While it has been over a full month waiting for official approval numbers, receipts and complete response statistics for November of FY 2022 to post, and after bemoaning the delay in one of posts yesterday, they popped up either overnight or early this morning. The full approval actions hit 67 (we unofficially missed by one […]