Halfway Through June 2021, Approval Actions Appear to Hit Sub-Par Numbers

We have reached the halfway mark of June and, as of the unofficial reporting through June 15^th,OGD has issued just 24 full approval actions and 7 tentative approval actions.  Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the number of applications that FDA has acted on is actually 2 less because of the partial approval and the way OGD reports these figures in the daily approval actions.

If the rate of approval actions holds throughout the rest of the month, OGD would have processed 62 approval actions, which falls below any month so this far in FY 2021.  We will report once the month is over and before OGD issues their official count for this metric around the second week in July.