With numbers reported to date through March 15th, it looks like the OGD will reach ninety approval actions this month. There have been thirty-eight full approvals and seven tentative approvals reported so far this month. With the OGD averaging eighty-eight full approvals for the first five months of FY 2019, it will need to push to get to that number by the end of the month, but it is still possible. We have not seen a 10+ approval day so far this month, which has become a marker for the past five months.
With October 2018 seeing one-hundred and ten approvals and November pushing out ninety-nine, we have seen a drop-off to an average of seventy-seven full approvals per month in the last three months this FY. Projections still have the OGD setting a new record; however, by how much will depend on what fills the approval pipeline in the remainder of the year. This is the first year where more ANDAs have been approved than received, at least through the first five months, with only one month’s (December, a high‑submission month due to the last-of-the‑year push to get ANDAs in before the end of the year) receipts exceeding full approvals. This begs the question of whether the input drives the output? But, remember, there are still a bolus of older ANDAs, some of which pre-date GDUFA, still in the review queue.
We will study the numbers as the year progresses and keep you informed of any trends of note.