OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown. Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one ANDAs and tentatively approving twenty-one ANDAs.
In the first four months of FY 2019, OGD fully approved 359 ANDAs and, based on a straight-line projection, it would appear that, if all things remain the same, OGD will hit a record-breaking 1,077 ANDA approvals or some 27.5% more than last FY’s record-breaking 781. Tentative approvals for the first four months of FY 2019 totaled ninety-nine, which could also translate to just under 300 tentative approval actions for FY 2019, if, again, the rate of monthly actions remain the same. The previous record for tentative approval actions was 190 in FY 2018 (a 33% higher total). Of course, tentative approvals can fluctuate more, based on the patent and exclusivity expirations and challenges, unlike full approvals.
The number of Complete Response Letters jumped back over the 200-mark (206). There are no figures posted yet for either the December or January receipts. As explained in previous posts, the FDA is trying to figure out how to assess and assign submission dates based on the inability to receive fee-paying applications during the government shutdown. Hopefully, we will see receipt numbers once the FDA further updates the metrics towards the end of February. The January official approvals and complete response numbers can be seen here.
