Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers.  At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry.

We reported fifty‑eight full‑approval actions and eleven tentative‑approval action for a total of sixty‑nine approval actions for October (see post here) and now we can report on the unofficial November numbers:  fifty‑seven full‑approval actions and eleven tentative‑approval actions for a total of sixty‑eight.  The slight  drop in the may be due to the Thanksgiving holiday as well as Veterans Day, or maybe it was just a low count for approval actions in one of those “not so good months.”

Hopefully by mid‑December, as noted in the post “Where Have all the Officials Stats Gone – Long Time Passing” (see first link above), we will have a look at the official numbers as well as the other metrics we usually see, sans any changes in the reporting based on the GDUFA III commitment letter.