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Two-Thirds of the Way through January, Approval Action Totals Signal A Below-Average Month

With seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions.  The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions.  Unless the end of the month picks up, we could see the slowest month for approval actions this FY.

With the influx of December new original ANDA submissions, we should see a pickup in actions in about ten months; however, the lower approval actions seen so far this year are a bit puzzling since many of the older applications have not only hit their ten-month goal date, but many amendments to complete response letters keep coming into the Agency and, for multiple cycle reviews, one would think more would be moving towards approval action.  In addition, first‑cycle approval rates have been inching up towards 20%.  So, why the decline?

I guess trying to make sense of the approval-action numbers for those of us in the industry is more of a guessing game as the transparency from the OGD is a bit opaque on this issue.  We will continue to closely monitor the available statistics to ensure that our readers can at least make the best guess along with us!