December of FY 2021 sure didn’t break any records as the OGD managed to eke out only 34 full‑approval actions and 13 tentative‑approval actions. We would have to go all the way back to February 2018 to find a lower full‑approvals total for a month, and the total for that month was 32. The tentative‑approval actions total of 13 is fairly average according to the past few years. Thus, the total number of estimated approval actions for December is 47, and, again, we need to go all the way back to that same month, February 2018, to find a lower total number of full- and tentative-approval actions of 37.
Can we blame it on the holidays, COVID, or just not enough ANDAs meeting the FDA’s approval requirements? Who knows as it is likely a combination of all of those factors. The OGD has still not posted the approval actions, receipts, and complete response letters for November 2021 (which is kind of odd as it usually releases those numbers about two to three weeks into the following month). We will report on those figures once the Agency posts them on its Generic Drugs Program Activities Report – Monthly Performance for FY 2022, which can be found here.
Numbers gathered for this post come from the FDA’s All Approvals list, which can be found here (just search for December 2021 figures).