Even with the 35-day government shutdown and the stress that came with it, it appears that OGD has broken the 100 approval action barrier again with what looks like (so far) 102 approval actions posted for January as of February 4th. The data is taken from the FDA All Approvals list here . In the first four months of FY 2019, OGD has issued at least 100 approval actions in each month, with January figures (again, at this moment, as there are always a few stragglers that appear after the end of the month) at 79 full approvals and 23 tentative approval actions.
While we await the official numbers for January, which should be coming out in a week or so, there is a hint that OGD will almost certainly break approval records in FY 2019. We will do a straight line estimate when OGD issues the official count and we will also see what they report for December and January receipts of original ANDAs once they apply the shutdown acceptance criteria they have established (see post here).
This could be a wild year! Welcome on the ride!
