The number of approval actions that were posted for the first half of April 2026 might be a record. The FDA issued 59 full-approval actions (helped a great deal by full approvals of 24 ANDAs and 5 tentative approvals on April 6th for Dapagliflozin single entity and combination products on the day of the expiration of the innovator product’s limiting patent). The 59 full approvals are a bit higher than the average number of full approval actions seen in the twelve months of FY 2025 (monthly average of 57.4) and the first five months reported in FY 2026 (56.2/month). From my experience at the FDA, I can tell you that organizing approval packages for 29 applications, for which actions were issued on the patent expiration date, is a monumental task.
As far as tentative approvals go, the OGD has issued 11 tentative approval actions in April. That means the total number of approval actions for the first fifteen days of April was 70. However, the number of ANDAs acted upon was actually 68 as two ANDAs were listed as separate approval actions but with the same ANDA number. Thus, of the 59 full approvals, only 57 will show up when the FDA issues its official April statistical report. Remember, approval actions are one of the ways that the OGD keeps track of its productivity, but the official totals reported in the Generic Drugs Program Monthly and Quarterly Activities Report identify only each application, not separate approval actions.
If the rest of the month continues at this pace, we may have a final number of total approval actions that has not been seen in the last two to three fiscal years.
