The FDA has posted a total of 82 approval actions in March to date on the FDA All Approvals page. Of course, these numbers could change over the next few days as the posting of some applications is delayed. The OGD’s approval pace has been consistent over the past eighteen months.
During March, the OGD issued 58 full-approval actions. It should be noted that one of the full-approval actions was for a second strength of a product in the same application. This typically occurs when there is a patent or a specific period of exclusivity impacting the original approval date of one of the strengths. Because of this, if no additional full-approval actions are posted, you will likely see one less full approval in the March Generic Drugs Program Monthly and Quarterly Activities Report. The difference in reporting (between the two reports) occurs because the OGD lists all of its approval actions in the Daily Approval Report as a measure of its workload, even though there could be multiple approval actions for the same ANDA at different times when a certain strength is blocked by a patent or exclusivity issue.
The OGD also issued 24 tentative-approval actions, again on pace with the last eighteen months. It seems that the OGD has settled into more of a steady state of approval output.
We’ll have more for you when the official March 2026 statistical report is released in a few weeks.
