OGD Updates June Stats and Preview of July Approval Actions

The Office of Generic Drugs (OGD) updated the June statistics late yesterday (here).  Here are some of the highlights!

The refuse-to-receive (RTR) actions were low again with just five RTRs issued in June and all were for standard applications.  The total for the year, based on the last nine months (forty-two so far), should be far less than the 127 RTRs issued in FY 2018.

The OGD acknowledged fifty-nine ANDAs in June (the second lowest month since October 2018).  Of the forty-five ANDAs approved in June, eight were first-cycle approvals (about 18%) and of the seventeen tentative approvals, two were first-cycle (about 12%).  For the first nine months of FY 2019, first-cycle approval actions averaged 15%/month and Tentative Approval actions averaged 11%/month.  So, June was pretty much in-line with the percentage of first-cycle actions thus far this FY.

Complete response letters (CRLs) were at 180 and slightly below the nine-month average of 194.  There were 179 amendments (the lowest of the FY) with a breakdown of major amendments beating minor amendments by ninety-one to eighty-one.  One would think that the industry would have really turned around the number such that more minor amendments would be coming out of the OGD, signifying that the industry is doing a better job.  For the nine-month period, major/minor amendments are just about split (888 to 843).

The number of CBE supplements hit a low for the FY at 594, but that is still a lot of monthly work that OPQ must deal with.

Controlled correspondence in June was the second highest this FY with the OGD receiving 286, only exceeded by the 291 submitted in April 2019.  The full set of statistics for June 2019 can be found here.

Now for a preview of the July approval actions.  The OGD saw a slight bump back up in July with a total of seventy-five approvals actions (sixty-one full approval actions and fourteen tentative approval actions).  This beat the sixty-two approval actions in June (forty-five full and seventeen tentative) but was also the second lowest month for approval actions for this FY.  These numbers were obtained through the FDA All Approvals List (here) and are tentative as the OGD has not yet updated its activities report with the official numbers.  We will update this post and give full FY estimates when the OGD publishes the official numbers, likely sometime next week.

Three months to go in this FY and then on to a new set of FY 2021 GDUFA fees (see post here).