The OGD updated its usual February statistical report late yesterday (April 18, 2022) to complete the month’s reporting. To start out with a bit of a startling number, February saw nine ANDAs issued refuse‑to‑receive (RTR) letters. This is triple the number in any month this FY (only three RTRs were reported in each of the previous four months, which was good news for sponsors). Does this signal a backslide in application quality or is it just an anomaly? It will take a few more months to see whether a trend is developing. However, there was one month in FY 2021 when the OGD did issue eleven RTR letters. So, we are hopeful it is not a trend.
The OGD did have the highest month for issuing acknowledgement letters for new ANDAs, with ninety‑one issued. Once again, as previously acknowledged, this is likely a function of the 135 ANDAs that the OGD received in December. This should even out soon as all of those ANDAs move through their completeness and acceptability reviews.
Of the fifty‑nine ANDA full‑approval actions previously reported, eight (13.5%) were first‑cycle approvals and, of the twelve tentative‑approval actions also previously reported, two (16.7%) were first‑cycle actions.
The issuance of complete response letters dropped to the lowest this FY at 141 while the OGD issued a whopping 422 information requests (IR), far and away the highest number of IRs issued this FY and actually the highest number since August 2018 when the OGD issued 436. Discipline review letters were in the current normal range with 168 issued for February. Other stats looked to be in line with previous months this FY with the exception of controlled correspondences, which saw a jump up to 341 (the highest so far this FY). Industry does have a lot of questions, doesn’t it?
The full OGD report can be viewed here.
We await the official March stats for approval and receipt actions so we can update the estimated totals for the full FY. Those projections will be based on the official actions for the first six months of FY 2022. Wow, where does the time go? GDUFA III will be upon us before we know it!