March 2023 was an outstanding month for approval actions, with OGD unofficially issuing 123 total approval actions comprised of 95 full approval actions and 18 tentative approval actions. There were other months with 100 or more total approval actions, but we have not seen that level of approval productivity in a while. The record of actual full and tentative approvals (not approval actions – see below for further clarification) is held by the back-to-back months of October and November 2018 when OGD issued a total of 132 approvals each of those months.
Now – the tricky part of the explanation. There were nine (9) second strength full approval actions (based [I assume] on previous strengths approved in the same application, but with these nine (9) approval actions having being delayed by either patent or exclusivity) and one (1) tentative approval action that could be a second tentative approval letter issued after an amendment. So, if we have reasonably captured all of the approval actions for the month (remember, some are slow to appear on the FDA’s daily list (here) or all approvals list (here; be sure to search on March 2023), we should see about 86 full approvals and 17 tentative approvals posted on the Generic Drugs Program Monthly and Quarterly Activities Report (here) in a little more than a month. For a further explanation of what might on its face seem like a discrepancy in reporting approval numbers versus approval actions, see our previous post here which addresses this issue.
Nonetheless, March is shaping up to be a very good month for OGD. Verification will come when the official statistics are reported, which we will of course share here.