January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days. Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List (here – make sure to search the appropriate month of interest). As of February 7, 2022 at 11 a.m. Eastern Time, the FDA had posted sixty full‑approval actions and seventeen tentative‑approval actions for a total of seventy‑seven approval actions for the month. This is the highest number of total approval actions since February 2021. And as an FYI, February is starting off strong but there are two fewer days in the month as well as a Federal holiday so we’ll see how it fares as we move towards the Ides of March.
As often occurs, there may be a couple of stragglers that appear in the official totals (I found four extra tentative approvals that were posted after February 5th so I’m glad I waited another two days before writing this post!), so maybe the number will even go higher when the official numbers are posted at some point later this month. Let’s hope this is a good sign!
