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 we reported only 16 full approval actions and one (1) tentative approval action.
There is still a discrepancy between the number of tentative approval actions officially reported by OGD in September 2021 (see post here) and what currently appears on the FDA’s All Approvals page. We reported three (3) tentative approvals in our unofficial post (see second link in this article) and OGD reported 10 in their official total for tentative approval actions for September and we wondered where the other seven (7) were. Well, a check of the September All Approvals List this morning shows only eight (8) tentative approval actions for September, not the 10 that OGD reported. About 2 years ago, there was a problem with tentative approval actions between the FDA daily approvals list and All Approvals list. I hope that same problem is not back. We will keep an eye on the All Approvals list to see if the other two tentative approval actions show up, as at least five (5) more did after the official total was reported in the Generic Drugs Program Activities Report – Monthly Performance (here).
