According to the first FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here), the OGD had a good month for approval actions, issuing 62 full-approval actions and 20 tentative-approval actions for a total of 82. Only one month in FY 2024 had a higher combined total for these two metrics. That’s the good news!

The bad news is that the OGD received only fourteen new ANDAs in October. Frequent readers of this blog know that I’ve been worried about the number of new ANDAs being submitted for over a year or two. I don’t think we’re going to see any years of 800, 900, and certainly not 1,000 new ANDA submissions again! With a number of new firms’ names appearing in relation to ANDA approvals in the FDA’s daily approval log, what I’m hoping is that these firms, which are new entrants to the generic space, will begin to fill the void by seeking approval for some of the ANDAs that have “disappeared” for a number of reasons, including consolidation in the industry and existing firms shifting their resources into development of complex generics or towards biosimilars. Hopefully these new entrants into the generic business will slowly contribute to a rise in the number of new ANDA submissions over the next few years. This is not a new phenomenon; we’ve seen this before, especially as consolidation occurs. However, with the continued downward pressure on margins for generics, it is unclear at this time whether this issue will negatively impact newcomers to the generic market.

Anyway, with this venting out of the way, let’s take a deeper dive into the new statistical report. Of the 62 full ANDA approvals, six were for first-time generics and only eight (13%) were first-cycle approvals. And while five (25%) of the twenty tentative approval actions occurred in the first cycle, this is not a good predictor of when those ANDAs will ultimately (if ever) be approved. The big question relative to first-cycle approvals is, when is industry going to see a significant rise in the percentage of approvals made during first review cycles? With all the new “efficiencies” baked into GDUFA III, we haven’t seen any real improvement in this metric. This, I believe, is something that must be addressed early in the negotiations for reauthorization of GDUFA IV.

Elsewhere on the statistical score card, the number of complete response letters issued was 118, only higher than in six of the months of FY 2024. As a matter of fact, in FY 2024, the monthly average of CRLs issued was 134.8 for the first six months; in the second six months, the monthly average was only 100.8. This would be good news if the number of ANDAs approved had increased as well, but it did not. We will need to keep a close watch on CRLs over FY 2025 and hope that the downward trend seen in the second half of FY 2024 does not continue.

The OGD issued 407 information requests (IRs) in October, a higher number than in any month of FY 2024. The IRs were evenly split between original ANDAs (204) and supplemental submissions (203). The OGD also issued 168 discipline review letters and approved 160 prior approval supplements in October.

Two bright spots for industry: (1) no ANDAs were issued refuse-to-receive letters in October; and (2) the OGD issued 81 acknowledgements for newly received ANDAs, knocking down the backlog of completeness and acceptance reviews for the massive number (140) of new ANDAs submitted in September.

Relative to the overall ANDA workload, the number of ANDAs pending FDA action dropped 31 from September’s 1,511 to 1,480 in October, while the number of ANDAs awaiting applicant action was 1,941, only one less than the September figure.

We already discussed the fourteen new ANDA submissions above, so let’s now look at some of the other receipt numbers that add to the OGD’s overall workload. There were 172 ANDA amendments received (54 classified as major, 60 classified as minor, and 58 unsolicited amendments). In addition, the OGD received 911 supplemental applications (762 for changes being effected and 149 prior approval supplements). Controlled correspondences clocked in at 318 submissions, which is on the high side of average from last fiscal year.

For those of you who are statistic freaks, please review the other metrics (e.g., meeting requests and DMF reviews), which can be found in the full report at the link cited at the beginning of the post. Enjoy!