August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications. Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review applications submitted each month. This could be because firms are rushing to submit priority-review applications as soon as possible to secure a potential period of exclusivity. It is difficult to get a real feel for this issue since the number of each type of application submitted each month is not broken down by standard and priority status.
As to first-cycle approvals for August applications, of the sixty-six full-approval actions, ten or 15% were approved in the first cycle. However, of the thirteen tentative-approval (TA) actions, none were approved in the first cycle. This is the first month of this FY where no TA actions were reported as first‑cycle approvals. There could be a multitude of reasons, for instance remember that the OGD began reporting reissuance of TA actions if the firm amended its application after it received its first TA action. Sometimes, it could relate to a change in the patent status or period of exclusivity changes where the firm has previously received a TA action.
The OGD acknowledged eight-seven ANDAs in August. Reviewing the remainder of the metrics, there were really no other figures that were much different than in previous months. The entire set of metrics can be viewed here.
As noted in various other posts, because of a data migration issue occurring at the FDA in September, we cannot make any accurate prediction of the number of approval actions for September 2019 so we will report this figure when the OGD announces its official numbers.
