Despite a slow start to FY 2018 due, in most part, to the elemental impurities issue, the Office of Generic Drugs (OGD) has broken the FY record for number of approvals. We are not quite sure by how much just yet because the numbers can continue to roll in over the next few days, but as it stands now, OGD fully approved 54 ANDAs and tentatively approved 11.
With the 54 approvals reported so far for September (here), OGD stands at 773, with likely a few more being posted before the official total is reported. The previous record was 763 in FY 2017. This bodes well for the generic industry and the Agency. I know the expectations are greater from the industry perspective, especially since the hikes in the fees, but maybe once the GDUFA II kinks are worked out, the approval numbers will be even higher.
We will keep on top of the numbers and provide an update once the official numbers for September are reported by OGD.