We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions. We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two. Thus, the total number of approval actions was fifty‑six, much better than the forty‑seven we reported. Nine of the tentative‑approval actions were posted well after January 5, 2022 when we posted the article.
Complete response letters (CRLs) hit a low of 108 for December (the previous low of eight‑two was notched in July 2017), while December, as usual, was a banner month for the submission of new ANDAs with 135 reported. The last time that many ANDA submissions were posted was December 2019 when 149 were submitted. December 2020 saw 124 ANDA submitted.
So, in December, submissions were up, CRLs down, and approvals not quite as low as we had previously reported. Don’t see any reason for the low CRL number other than, perhaps, holiday vacations. We will report on mid-month January 2022 approval actions towards the end of the week.
