Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions. That is a total of (obviously) thirty‑one approval actions. Given that number, if the OGD could double its approval output by the end of the month, that would place the total at sixty‑two, which is not too bad! However, given the holiday coming up and with only nine reporting days left in December, along with the usually large number of staff on vacation at this time of year, unless there is a Herculean effort this last week and a half of the month, I’m afraid that this will be one of those down months that the OGD said will occur from time to time.
But you never know! This is (of course) the time that the New Drugs staff typically tries to push approvals out prior to the New Year and, thus, anything can happen. Also, the OGD reported a number of imminent application approvals in its October report, which could make it through the system, but since we haven’t seen the November report yet, we don’t have any view into whether there were more imminent approvals for which the GDUFA date was extended in hopes of bringing the applications to pending final approval, potentially boosting the total for December.
To see the all of the approvals reported, please visit the FDA’s All Approvals and Tentative Approvals: December 2022 (here) and, for generics, look for original ANDAs.
