The OGD published the second month of the Fiscal Year (FY) 2025 statistical report titled, Generic Drugs Program Monthly and Quarterly Activities Report (here). There is some continued good news and also some troubling news in the report.
On the positive side, we previously reported (here) in our unofficial posting, the full approval actions as 58, with tentative approval actions of 12. Apparently, there were 5 late entries in the tentative approval actions that bumped the official total of tentative approval actions to 17. Therefore, the official number of full and tentative approval actions for November 2024 was 75.
Of the 58 full approval actions, 4 were for first-time generic approvals and 14 (24%) were approved in the first cycle. That is a better percentage for first cycle than we have recently seen, and we sincerely hope that it continues to rise. Of the 17 tentative approval actions 3 (17.6%) were first-time approvals.
Complete response letters dropped to 87, the lowest number seen since July 2017 when 82 were issued. Refuse-to-receive letters were sent regarding two ANDAs, and the OGD acknowledged 59 new ANDAs. Prior approval supplement approvals we only 86, the lowest number since they first appeared on this statistical report in FY 2023.
In November, the OGD reported issuing 344 information requests (195 for original applications and 149 for supplemental applications) which is not bad. They also sent out 128 discipline review letters (DRLs) which is on the very low side (last month they sent out 168 DRLs and the FY 2024 monthly average was 183).
Now the worrisome news. The OGD received only 18 new ANDAs in November after receiving an anemic 14 the month before. Recognizing that a lot of ANDAs were submitted before the GDUFA ANDA fees rose in October, a second month of such a low number of new ANDA receipts causes some worry about the resilience of industry’s ANDA pipeline. We will keep a close eye on that!
The OGD received 812 supplements (665 CBEs and 147 PASs), which is indicative of another worrisome trend, as in October 2024, OGD received 911 supplements, and FY 2024 monthly average was 984! Another big drop was seen in the number of controlled correspondence letters to 231, down almost 100 from October 2024 and the lowest since December 2023.
As far as total ANDA original application workload for FDA OGD, the numbers of ANDAs awaiting FDA action dropped 40 ANDAs to 1440 from last month. With a declining number of ANDAs being submitted, we are likely going to see that number decline further in future months. At the same time, the number of ANDAs awaiting applicant action dropped by only 13 to 1928 (526 are from tentative approvals and 1402 related to complete response letters). With the lower number of ANDAs being submitted, it is possible that applicants are concentrating more on responding to CRLs that are in their court rather than pressing for submission of new ANDAs.
While it is still early in FY 2025, the decline in the OGD receipts and some areas of output still have my antenna on high alert. Once the December official stats are released, we will report not only on that month’s statistics but will also see how the apparent lull in activity has impacted mean and median approval times for the first quarter of FY 2025.
For a complete listing of the November 2024 statistics please see the link provided in the first paragraph of this post.
