February is a short month in workdays and it may be the same for approvals. Through February 17th, the OGD has issued twenty‑five full‑approval actions and fourteen tentative‑approval actions. With only six reporting days left this month, unless there’s a big surge in the next few days, we may be looking at the fewest approval actions for any month this FY.
We know that there are issues with getting approvals, or any action (CRL) for that matter, out on applications cursed by the nitrosamine situation, and perhaps this a partial hit to the approval numbers seen thus far this month. Once those issues are resolved, we may see a rise in approvals given the large number of products that have been plagued with nitrosamine issues. As we all know, it is no longer just ranitidine affected by this issue as the list of impacted products seems to grow larger every month.
But who knows, the OGD might surprise us even though the end of the month is in sight!
