We Await Official August Approval Results, But Here is the Unofficial Scorecard

According to all of the published approval data on the FDA All Approvals List (here) and the Drugs@FDA: FDA Approved Drug Products (here), the OGD has taken full-approval action on fifty-nine ANDAs and tentative approval action on twelve ANDAs for a total of seventy approval actions in August.  But wait – there is something amiss!  We know that the OGD approved at least one ANDA on August 30^th that did not appear on either list and, to be quite frank, there were no full approvals listed for the 28^th, 29^th, or 30^th of August, and only one tentative-approval action on August 28^th was reported as of this morning.

This is highly unusual as the list was supposed to be updated within a day after approval.  We do know that the unofficial counts are usually a couple of actions off due to the reporting delay, but we are three workdays after the holiday and would expect to have a few end-of-month approval actions to view.  Thus, we believe that the full- and tentative-approval actions will rise when the OGD issues its official numbers.  If not, this will be the second lowest month for approval actions this FY.