Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions.
November has at least two holidays where the Federal government is closed, and we are past one of them. With 39 total approval actions it looks like OGD could be back into the high 60’s or even low 70s for approval actions this month. That should bring some Thanksgiving cheer to the generic industry.
The Official approval actions for October are now reported as 49 full approval actions and 14 tentative approval actions for a total of 63 total approval actions for the first month of FY 2022. These numbers are very close to the numbers reported in our post (here), although official OGD final numbers for October shifted one full approval to tentative and added one more tentative approval that popped up after our unofficial reporting. In addition, 6 of the full approvals were first time generics.
OGD also reported 152 complete response letters issued in October and that a lowly number of new ANDAs only 24 were submitted in that month. That was a bit more than the lowest month in FY 2021 where again in October there were only 20 new ANDAs submitted. This low October number is typical as firms usually have a rush of ANDA to submit at the end of the FY in September. The start of FY 2022 certainly seems to point to a better approvals year for OGD.
