I believe everyone likes seeing the progress of ANDA approval actions, and hold that as the primary measure of success of OGD. I know that has been the case ever since Hatch-Waxman was implemented in November of 1984. So I continue to track this metric very closely and at least through the morning of March 7, 2022, the FDA All Approvals web site (here), 60 ANDA full approval actions and 8 tentative approval actions for a total of 68 approval actions for the month. While not quite the 80 seen in January, the total for February is hopefully going to be the new floor for the “bad” months as it is better that the 56 noted in December 2021.
March 2022 is starting off slow with only four (4) ANDA approval actions in the first three (3) days of reporting, compared to the quick start in February where the first three (3) business days of the month saw 15 total approval actions. The figure for February is also notable since there are only 28 days in the month and there was one (1) Federal holiday, albeit, last February’s total was higher (79 total approvals actions in FY 2021), but let’s not read too much into individual month performances as the goal should be seen as the full FY total – that is when the horse crosses the finish line.
We may see a few more stragglers posted during the next few days but all in all, February looks pretty good. We will provide a full year estimate update once the official counts are provided in the Generic Drugs Program Activities Report – Monthly Performance 2022 (here). Watch for it in a week or two.
