The official August 2024 statistical report was published by the FDA on October 17, 2024 (here). Let’s run through the numbers and then we’ll take a look at the mid-month approvals for October 2024 (the first month of the new Fiscal Year 2025).
The official August approvals were a couple below what we had predicted when we did our unofficial estimate (here); we said that we noted the number of approval actions as 67 but, in reality, the OGD reported 65 full approvals in its monthly report. Looking back at the August approval actions, this is a case where the FDA actually approved new strengths of two products under the same ANDA numbers. In other words, for each of the two products, the second full approval came after the first strength was approved. This usually occurs when one of the strengths gains full approval but another in the same application gains only tentative approval, usually due to patent or exclusivity issues with that particular strength. In these cases, the OGD designates the original approval as ORIG-1 in the daily approvals list; once the exclusivity or patent on the other strength is either no longer relevant or has expired and the Agency approves it, it is designated as ORIG-2. Remember, in the daily approval listing, the OGD reports all “approval actions” on a given date. However, when the FDA produces the official number of ANDAs approved or tentatively approved in its Official Generic Drugs Program Monthly and Quarterly Activities Report, it collapses those approvals made at different times into a single final approval. It is for this reason that one must be careful in discerning between approval actions (which give the OGD credit for each approval action it takes) and final approvals, which represent the actual number of ANDAs approved, even if the approval actions on different strengths come at different times.
Of the 65 full approvals, 8 of the ANDAs were for first-time generics and 9 (or 13.8%) were approved in the first review cycle. In addition, the OGD took imminent approval actions on 11 different products (that is, delayed finalizing review when reaching the goal date because the OGD believed the application review could be completed shortly after the goal date). Imminent approval actions usually result in final approval within the next month. August saw 14 tentative approval actions with 3 (21.4%) resulting in first-cycle approvals.
The OGD issued only 96 complete response letters in August, the lowest in FY 2024 thus far. Refuse-to-receive actions remained low at 2, both issued in August. The OGD did issue 49 acknowledgment letters to new ANDAs. There were also 137 prior approval supplements approved, along with 357 information requests and 211 discipline review letters issued.
Continuing a disturbing trend (which we will discuss further shortly), the OGD received only 32 new ANDAs in August, the second fewest received in a month since the first month of FY 2024 when the OGD received a mere 26 new ANDAs.
The number of amendments submitted to the OGD was the second lowest for any month in the fiscal year at 158 (the monthly average was 194). The breakdown of the 158 amendments received is as follows: 55 were major amendments, 65 were minor amendments, and 38 were unsolicited amendments. The number of supplements received was 961, slightly below the monthly average of 980, of which 826 were changes being effected supplements and 135 were prior approval supplements. In addition, the OGD received 269 controlled correspondences.
The FDA reports that its overall workload for ANDAs that are pending in either the FDA’s court or in the sponsor’s court showed a slight downward trend in FY 2024. We began the fiscal year with the pending ANDAs awaiting FDA action at 1,477 and ended August at 1,440. The number of ANDAs awaiting applicant action dropped from 2,056 to 1,972 through August. While a drop in pending ANDAs awaiting FDA action should be good news, it could also be a reflection in the drop of new ANDA submissions (which at the end of August stood at 600 for the eleven-month total). In addition, the drop in applications awaiting industry action is, likewise, somewhat troubling as this could not only reflect the lower number of ANDA submissions but also a shift from sponsors’ concentration on the ANDA market and new interest in biosimilars or complex generics (which are more difficult and require significantly more investment by sponsors). Such a shift could result in fewer dollars being spent on fewer projects in the ANDA generics space. While the impact suggested by these numbers is just conjecture, the history of ANDA submissions and approvals indicate that it is worthy of further investigation and evaluation. ANDAs are the lifeblood of the OGD and, right now, it appears that the patient may need a transfusion should the observed trend continue.
Now, as promised above, here is a mid-month peek at the approval actions in the first month of FY 2025. Through October 16, 2024, the OGD has issued 28 full approvals and 5 tentative approvals for a total of 33 actions. If this rate continues, the OGD will have issued in the neighborhood of 56 approval actions and 10 tentative approval actions; however, there are only eleven reporting days left in the month. Not to belabor the point but this would represent a relatively slow start to FY 2025! I know that some months are good months for approvals and some are not, but the overall look at approvals must be taken into account and I still find the trend concerning.
