A Funny Thing Happened On the Way to See the FDA Monthly Approval Report

For a few days now, I have been scanning the FDA Monthly Approvals List (here) for November to keep up with the action at the Office of Generic Drugs (OGD).  Searches for approvals for November on this site have come back with the following notice after the report was run – Your selected month and year did not return any results. This was a bit surprising to me, given that it was a week into November. However, when performing my daily ritual of reviewing other CDER web page results in the What’s New Related to Drugs (here) section, I clicked on the New and Generic Drug Approvals tab (here) and lo and behold the usually listing was gone and replaced by a newly formatted list of both original and supplemental approvals.  This list did have several approvals of ANDAs in November and this is what triggered our interest in why the FDA Monthly Approval Report did not generate any results.

While not as easy to read as the previous format, all the same information is there and perhaps it is derived or drawn from another database that will be more complete than the FDA Monthly Approvals Report.  As previously reported (here), the approval numbers reported in the FDA Monthly Approvals Report never actually matched up with the final approval numbers reported by OGD’s Activities Report of the Generic Drug Program.  There were almost always discrepancies between the two sets of reports, as the former did not appear to have complete information.

We will continue to monitor the FDA Monthly Approvals page to see if the FDA populates that report further or if they are going to rely on the new version of New and Generic Drug Approval listing to provide ongoing information on new and generic drug approvals. We still await the update to the final September numbers for certain metrics in the Activities Report of the Generic Drug Program and also anxiously await the October FY 2017 statistics report to become available, and we will report on those statistics when they are released by the FDA.