On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below.
OGD issued five (5) refuse-to-receive (RTR) letters and all five (5) applications were for standard GDUFA II applications. In addition, OGD issued 94 acknowledgement letters for filing of new ANDAs. This is a number that has not been seen since February 2020 when OGD acknowledged 114 new ANDAs, and this is obviously a reflection of the number ANDAs that have come in. The higher the number of acknowledgements issued means that the previous few months had a robust number of submissions.
Of the previously reported 84 full ANDA approval actions (here), 11 (13%) were first cycle approvals, and of the tentative approval actions none were first cycle approvals in May.
Complete response letters dropped to 125 (second lowest month of the FY year), while information requests were back over 400 (409) and discipline review letters fell about in the middle of the pack for monthly issuances at 184.
There were 218 amendments received in May which is around the monthly average, but it is interesting that most major amendments were higher than the number of minor, with the exception of only one month so far this FY where the minor amendments were only one (1) more than the number of major amendments. Remember, major amendments have a significantly longer response time and could indicate that the firm’s responses are not as good as they should be.
Changes being effected supplements and prior approval supplements were within normal ranges with 665 and 95 submitted respectively.
Controlled correspondences were still over 300 (306), but were the lowest number submitted in FY 2022 thus far. All of the reported monthly final statistics can be reviewed at the link in the first paragraph.