Despite the Shutdown, January Approvals Look Fairly Strong.  Will FY 2019 Break Record?

With 5 working days left in January, and despite the turmoil this month has seen, we stand at 58 Full approvals and 17 Tentative approvals reported on the FDA All Approvals page (here) through January 24, 2019.

Looking at the first quarter approvals (October thru December), there were a total of 278 full approvals which, if straight lined, would place the total approvals for FY 2019 at an estimated 1112, which is a pace that could be some 30% higher than last year’s record of 781. While this early estimate is really predicated on two record breaking months (October and November 2018) for approvals, we will need to see how the figures go over the next few months before we can make any firm predictions.  After all, the 1112 number is approaching an average of 100 approvals a month for the rest of the year.  Ambitious, eh! Possible? We will see.