In the first 10 business days of February 2021, the Office of Generic Drugs has issued 30 full approval actions and 3 tentative approval actions for total approval actions thus far at 33. There are 9 business days left in this month and, of course, February is only 28 days in total. Even if the full and tentative approval actions double in the last 9 business days of the month, that would only put the total at 66. That would be the lowest total thus far this fiscal year and the lowest combined total since February 2020.
While the groundhog did not see his shadow earlier this month, signifying more winter, perhaps it will be more of winter’s cold for approvals this month as well. You may think – well, maybe February is the lowest month for approval actions every year because of the short month. Not true! But there is also the icy, cold, snowy winter weather that may be impacting our friends at FDA although most are still working remotely. Hopefully, there will be a spate of approvals in the second half of the month to prove that the “short month blues” are only about as fictional as the groundhog’s predictions!