Not the best news (even unofficially), as OGD unofficially issued only 41 full approval actions in August. This represents the lowest monthly number of full approvals in all of FY 2026 to date and with just one month left in this FY, OGD may be scrambling to get more out the door. Although if the first two days of reported September approval activity are any indication, FY 2026 may not be finishing on a high note.
In addition, August saw OGD issue the fewest number of tentative approval (TA) actions for the FY thus far with what looks to be 11 TAs. We say “looks to be” because tentative approvals sometimes show up over a week or so after the end of the month. However, the previous lowest month this FY for tentative approval actions was in July where OGD issued 18 TA letters, so even if a few TAs show up, August will still have the dubious distinction as the lowest the month in FY 2026 for approval actions.
It is also important to remember that TA approval actions could represent the second or third TA letter issued on the same ANDA product if a firm had to amend their original “TA-ed” application with a change since that places the ANDA back into pending status and resolution of the issue could result in a second (or in some cases, a third or fourth) TA letter issued for the same application. OGD does not report that metric and the only way one can tell is by looking at the application history.
With all that in mind, we are hoping for a better September to help round out FY 2026. We will keep you informed; however, don’t expect the final official FY numbers to arrive until late October or early November.
