March came in like a lion and looks to be going out like a lamb.  With seven reporting days left, we counted forty-nine approval actions and four tentative approval actions for the OGD.  These numbers are tempered a bit by the fact that (as we have mentioned previously) the OGD reports every action it takes on each strength in the daily approval postings, even if there are multiple strengths in the same ANDA.  This month so far, we must, therefore, reduce the forty-nine approval actions by six multiple strengths to obtain the actual number of ANDAs approved.  Thus, in all of the applications, there are only forty-three approval actions and four tentative approval actions so far in March.

We saw a higher daily rate of approvals earlier in the month than the last week.  Unless the rate significantly picks up in the next seven reporting days, we are set to see perhaps the lowest monthly total of approvals and tentative approvals this FY when the OGD reports its official numbers some time mid‑April.  We will update you in the first week in April with what we see as the unofficial reported figures from the daily approvals listing posted by the OGD.