It appears that the OGD has hit a new high for total approval actions in August, judging by the unofficial numbers gathered from the available FDA databases as of this morning. Yes, that’s right-a total of ninety-five approval actions (seventy-four full-approval and twenty-one tentative-approval actions), which eclipses the ninety-four total full- and tentative-approval actions (eight-four […]
Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions. Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]
When we did our peek at the June Approval numbers mid-month (here), we predicted that June would be a good month and, at the time, indicated that there would likely be approval actions somewhere in the mid-60s. Well, OGD put the push on, and they actually broke the 70 barrier with 71 total approval actions […]
It appears that the tentative approvals for both May and June began appearing in force on the FDA’s All Approvals list and in the daily approval postings sometime this week. With that in mind, I want to update the unofficial approval action totals for May 2022, which we first reported here. The All Approvals report […]
In my post of May 3rd (here), I raised a concern about the number of approvals posted in the month of April 2022 and the fact that there were quite a few days in April where there were no or few approvals posted. I followed up with the FDA Press Office to see what was […]
First of all, Happy St. Patrick’s Day! The luck of the Irish prevailed last night as, one minute after midnight on March 17th, the Notre Dame Fighting Irish basketball team won its NCAA play-in game in double overtime for a chance to play #6 seed Alabama on Friday. I guess I have some luck too […]
FDA approval actions listed through December 15th include only seventeen full‑approval actions and six tentative‑approval actions for a total of twenty‑three total approval actions. As it stands, if these numbers represent one half of a month, it would mean that, at the current pace, we would see forty‑six total approval actions for the month of […]
According to the FDA All Approval list, OGD reported 28 full approval actions and two (2) tentative approval actions thru 10AM ET on October 15, 2021 (here) for a total of 30 approval actions midway through the month. This is a more favorable figure than we reported for the midway point of September (here) where […]
Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action. If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program. […]
With 11 reporting days of August behind us and 11 to go, OGD has issued 31 full approval actions and 2 tentative approval actions. If the current rate holds true for the rest of the month, OGD could be back to well over 60 total approval actions in August. We have seen a slowdown of […]
