With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs. Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month for approvals. Unfortunately, it might not be a lean month for those of us that love the turkey and all the fixings.
In addition, the OGD has not yet posted the first month of the FY 2020 Activities Report of the Generic Drugs Program Monthly Performance, so we cannot verify the official approval actions for October 2019 as of the writing of this blog post. The report is usually out no later than two weeks after the close of the month. We will keep an eye out for it and will post as soon as it becomes available.
The current posted approvals can be found here on the Recent New and Generic Drug Approvals page (search up to fourteen days) or on the All Approvals list (here) for all approval actions for any month.
