Well, another good month for approval actions at the OGD as it keeps the approval train in high gear. There were 69 ANDA full-approval actions in May. Please note that three of the full-approval actions were approvals of second strengths for previously approved ANDAs that were likely the result of delayed approval due to patent or exclusivity issues. While the OGD counts these as separate approval actions when reporting on its work output, when it comes to approvals, the OGD does not count each individual strength when counting approvals so it will reduce the number of full ANDA approvals from 69 to 66 in its monthly approval report. In addition, there were 31 tentative-approval actions. Thus, a total of 100 approval actions were taken in May 2025, accounting for 97 total ANDAs.
There may be additional changes in the numbers when the official report is issued due to late corrections or additions that had not yet occurred on June 9th when this count was published on the All Approvals website (here).
This is the best month that the OGD has had for approval actions so far this fiscal year. As the OGD approvals continue to increase, and if the sluggish pace of the number of new ANDAs being submitted continues, the outstanding workload in the FDA’s court will continue to fall. New ANDAs are the bread and butter of a healthy generics program and generic drug marketplace, but if the number of ANDA submissions continues to fall, there will be concern about the robustness of the market. Falling prices, along with razor-thin margins for many generic products, do not help the situation. As an economics professor I had in grad school said, if you are losing five cents per unit, you can’t make it up in volume! If conditions continue, we may see manufacturers drop additional unprofitable products from their portfolios, which could potentially lead to an increasing number of drug shortages.
