Well, OGD is back over the 70 mark for total number of approval actions in a single month, with what appear to be at least 72-66 full approval actions and six (6) tentative approval actions reported, going by the numbers posted at 11 AM EST December 3 on FDA’s website. The last time OGD had more than 70 approval actions was April 2021. And as always, I am sure that we can expect a couple more stragglers before the official November numbers are reported by FDA in about 2-3 weeks.  We will let you know the final tally once the official numbers are released. To see the full approvals list, click here and select November.

With 63 total approval actions in the first month of FY 22, this could be the beginning of a spurt of approvals for OGD and may signal a better FY 22 for approvals.  The best news is that number of full approvals was the highest number of monthly approvals since February 2021’s 72 full approvals. With a couple of holidays thrown in in November, that is reason to say nice work, OGD!