OGD updated its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) on Wednesday, giving us a look at some additional metrics for the month of August.
For all the talk of Refuse-to-Receive (RTR) actions, OGD issued only seven (7) in August. Four (4) were for standard ANDAs and three (3) were for priority ANDAs. So far, this FY OGD has issued 42 RTRs for priority ANDAs and only 31 for standard ANDAs. This is surprising since most ANDAs are standard review, which appears to mean that either priority ANDAs are receiving more scrutiny in the initial completeness and acceptability review process, or sponsors are not taking the time to fully QC their submissions in a rush to get them to the Agency.
Of the 53 ANDAs approved in August there were only six (6) first cycle approvals, and of the 15 tentatively approved ANDAs only two (2) received that designation in a single cycle. Information Requests (IRs) and Discipline Review Letters (DRLs) were very high with OGD/OPQ issuing 436 IRs (third highest for any month in FY 2018 and 248 DRLs (second highest monthly total for the FY).
OGD/OPQ received 271 amendments to ANDAs (the highest monthly total for the FY) with supplements and controlled correspondences, coming in at about the typical monthly average. The increase in number of amendments reflects industry responses to the record number of complete Response Letters issued in FY 2018.
So far this FY only 59 pre-facility submission correspondences have been received by OGD. Not sure if that is because of fewer products being eligible for priority review, or the 60-day pre-submission requirement to gain two (2) months in review time (remember 2+8=10, and standard review time is 10 months).
We will be back when OGD finalizes the approval and receipt and complete Response Letters data for the last month in this FY.
