While April showers may bring May flowers, the number of unofficial April ANDA approvals sure is a welcome event. April saw full approval of 87 ANDAs, the highest number since August 2023 when the FDA approved 98. April’s total was bolstered by the 24 full approvals of dapagliflozin single entity and combination products on April 6th. In addition, the OGD issued 18 tentative approval action letters, thus the total number of approval actions for the month of April will be about 105. The last time the OGD went over 100 total approvals was in August 2023 when it issued 110.
There were a couple of approval actions issued for the second strengths of previously approved applications, signified by the designation “Orig 2” in the daily approval database. These will likely show up as a couple fewer approvals in the official statistics when the OGD issues its official Generic Drugs Program Monthly and Quarterly Activities Report.
This is most action we’ve seen for monthly approvals in almost three years, and it bodes well for the full fiscal year approval total, especially if the OGD continues on its current trajectory. More about that when the official numbers come out! However, we still have a growing concern relating to the lower number of new ANDA submissions coming into the OGD; this is something we’ll discuss further when the official full statistics become available for the seventh month of FY 2026 in a few weeks. Stay tuned!
