We previously intimated (here) that March came in like a lion but might go out like a lamb; however, thanks to a flurry of approval actions in the last four days of the month, it looks like the lion might have stayed in the approval picture for most of the month. The unofficial number of approval actions of sixty‑nine and ten tentative-approval actions boosted total approval actions to just under eighty (seventy‑nine).
Please realize that this month included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change in reporting that the FDA made over a year ago. From the data reported to date, it appears that for a clear picture of the number of ANDAs approved, we will need to subtract six approvals reported as duplicates in the daily reports (here). Thus, we are predicting sixty‑three approved ANDAs to be reported when the official figures are released on the Generic Drugs Program Activities Report – Monthly Performance for March (here) once it is updated for March 2021. Therefore, while the OGD reported seventy‑nine approval actions for March, we expect sixty‑three full‑ANDA approvals plus ten tentative‑approval actions to be reported for a total of seventy‑three approved applications. We don’t really have an easy way to determine the duplicate number of tentative-approval actions because the FDA may issue multiple tentative-approval letters based on amendments to previously TAed ANDAs, resulting in multiple reports of TA actions for the same ANDA. I know it gets confusing, but this is how it is, at least for now.
