The Office of Generic Drugs unofficially issued 52 full approval actions and 11 tentative approval actions in December 2023. Not bad considering it was the holiday season and (in fact) a tad better than the most recent holiday season of December 2022 when OGD also issued 52 full approval actions and just 7 tentative approval actions.

Over the last three Fiscal Years, the December approval numbers have been low. However, prior to that, they were average or better than most months. Perhaps the increased level of reporting requirements under GDUFA III is having an impact on getting approval actions out, or it just might be that more applications were not in line for approval.

We will let you know when the official numbers are posted, and then take a look at the first quarter approvals along with other quarterly metrics that OGD produces.