January 2020 Approvals Well Below Average

The official OGD stats are out for approval and tentative approval actions, as well as complete response letters issued and receipts of original ANDAs.

In January 2020, OGD issued 49 full approval actions, the lowest by far for FY 2020. Of those 49, only one was cited as a first-time approval (I think this might be an error in reporting, as the first-time approvals are typically not reported until the full set of January stats are complete).  In addition, OGD issued 14 tentative approval actions.  We hit the number of approval actions correctly in our February 4th post (here) but missed the tentative approvals by 1 (we saw 13 at the time of publication, but OGD officially reported 14).  While tentative approvals are in line with those reported over the last 4 months, as noted above, full approval actions were low.  We are not sure why but there you go!

As far as complete response letters go, this is the first month in FY 2020 that the total CRL issued was above 200 (207 to be exact) but not by a lot, with 2 of the last 4 months hitting 197.  Original new ANDAs received in January fell back to a FY 2020 norm of 59, with the exception being December,  which we previously reported at 149.

The full report can be found here.

We will update you when all of the rest of the January stats are updated but, for now, we are somewhat concerned about the decrease in approvals, especially with a concerted effort by OGD to expedite certain approvals.