We hit the nail on the head in our August 2 post (here) as we reported sixty-one full-approval actions and fourteen tentative-approval actions for July 2019. This was the first time in a while that the official numbers did not change after our review of the unofficial counts from the FDA’s All Approvals page.
The total of seventy-five approval actions stands as better than the June figure of sixty-two, but still at the lower end of OGD activity for approval actions this FY. In the ten-month period thus far in FY 2019, the OGD has issued an average of eighty-one full-approval actions a month, which would lead to a yearly total of about 976 for this FY. Earlier in the year, the monthly rate had the OGD project to issue well over 1,000 full-approval actions, but the last few months of the FY year do not seem to support achieving the 1,000+ number, even though it will still smash the record of 781 full-approval actions in FY 2018 by about 200.
While ANDA receipts had been a bit anemic over the past three months, July saw the submission of 102 ANDAs (the third highest month for this FY) and, if the last two months of submissions are consistent with that level, receipts again could just about match full-approval actions. Remember September has historically been high as, after September 30, the ANDA fees change; however, this cycle, the FY 2020 ANDA application fees will drop about $2,500 per application. It will be interesting to see whether applicants hold off until October 1 to save a few bucks!
Complete response letters pushed back over the 200-level at 209 in July, barely over the ten-month average of 196. The OGD’s full Activities Report can be found here.