With six (6) reporting days left in the month, the FDA’s All Approvals List (here) has identified 43 full ANDA approval actions and 10 tentative approval actions. While this represents a bit slower pace for approval actions, there is still time to meet FY 2020 monthly averages by the end of the month.
We want to remind readers that some time back, the FDA switched from reporting approvals to reporting approval actions. The difference being that, once OGD issues a tentative approval (TA) action, if the sponsor submits an amendment changing the conditions of approval to the TA-ed ANDA, its status changes back to pending. Then, once the FDA has reviewed the submission and found it acceptable, OGD issues a second TA action letter, which is reported separately. This can happen multiple times throughout the pendency of the TA-ed application. The same thing can happen with full approvals, if there are multiple strengths and one strength was submitted at a different time, due to patent or exclusivity issues, or because the firm did not originally seek approval for all strengths for business reasons. The same can happen post full approval if an approval for an additional strength is later sought and approved through a supplemental approval. For example, an RLD has 4 strengths. An ANDA applicant seeks approval for three of the strengths in their original application and receives approval, which is counted as one (1) approval action. Subsequently, the ANDA sponsor supplements its application for the 4th strength and gains approval. That also counts as another approval action that will be folded into the original ANDA. However, had the sponsor included all 4 strengths in its original submission, it would only have resulted in a single approval action. For those old enough to remember the time when each strength had to be submitted in a single application, this presents a dilemma when looking at historical approval numbers as noted below.
The reason we point this out again is because the comparison of approvals from past GDUFA FYs may not be practical because the counting and reporting system for approvals and approval actions are a bit different. The other thing to remember is that, reporting a total of full and tentative approval actions does not mean an additive effect on the total number of different approved applications, but rather, that a portion of full approval actions have been previously tentatively approved and then move to full approval once the patent or exclusivity issues are resolved. So just be mindful of this when looking at the current and past FDA reports for these metrics. OGD reported that they made this change in reporting approval actions to capture their effort and productivity.
