In December, the third month of FY 2026, the number of unofficial approval actions fell significantly from those in the first two months, with the OGD issuing 41 full-approval actions and 13 tentative-approval actions for a total of 54.
* December numbers are unofficial but should be close to final.
The reasons are not obvious as December approval actions hovered at about the monthly average in previous years. This dip could have been because of the prolonged and unexpected holiday schedule (three days versus one day due to the President giving federal workers an additional two days off at the last minute). Approval work would have been at a standstill for those two extra days; however, the last few days of December did not show a significant increase in approval actions as the OGD issued only 5 full approvals and 1 tentative approval during December 29 through 31.
We’ll report further on full-year estimates of ANDA approvals when the official numbers for December are released. In addition, we’ll provide an estimate of new ANDA submissions and first-quarter mean and median approval times after the December Generic Drugs Program Monthly and Quarterly Activities Report is issued.
