The official numbers for June 2024 are in and posted on the FDA’s website here. The OGD issued fifty final full approvals along with fifteen tentative approvals in June. Of the fifty approvals, four were first time generic approvals and nine (18%) were first-cycle approvals. Of the fifteen tentative approvals, there were no first-cycle approvals. Based on the first nine months of the fiscal year, it appears that the OGD will likely issue about 670 full approvals this FY, assuming that the rate of approvals remains unchanged. If this number stands, it will be well below the number of approvals we have seen since FY 2015 under GDUFA.
The issuance of Complete Response Letters (CRLs) has been a little anemic over the last three months and the OGD issued 116 in June (in May, the OGD issued only 87, a low for FY 2024, and April showed just 116 for the third lowest of the fiscal year). The OGD issued only two refuse-to-receive letters in June.
The OGD approved 93 prior approval supplements, which is the lowest number for any month thus far in FY 2024 and well below the monthly average of 145. Information requests remained steady at 331, but this represents the second lowest in a month of this fiscal year (January had 318, and the monthly average through the first three quarters of FY 2024 was 355). On the other hand, discipline review letters registered the second highest of the fiscal year at 227.
On the receipt side of the house, the OGD received fifty new ANDAs in June which will (if the trend continues) provide a full year total of about 695 new ANDAs. This is a low number that we have not seen since FY 2015 when only 539 ANDAs were received (note: FY 2015 was the year of a revision to the refuse-to-receive requirements and the OGD rejected 236 ANDA submissions).
ANDA amendments are down as well with the OGD receiving just 154 from industry, the lowest number in any month thus far this fiscal year. The number of supplemental submissions also dropped to the second lowest received in a month this fiscal year (835) with the lowest (788) having been received in November (note: the monthly average of supplemental submissions in the first nine months of this fiscal year was 964).
As far as the OGD review workload goes, there was not much change in the number of ANDAs awaiting FDA action at 1,484 (down from 1,486 last month) or the number of ANDAs awaiting industry action, which also dropped only by two from 2,006 to 2,004.
At the end of the third quarter of FY 2024, there haven’t been any major changes in the ups and downs that we usually see in the mean and median approval or tentative approval times for original ANDAs, as shown in the table below.
Well, that is it for now. You can review the other statistics available in the report at your leisure by clicking on the link provided above. I can tell you that I am still concerned about the lower number of ANDA submissions, but, as noted in a previous post, with GDUFA fees rising substantially for FY 2025, perhaps the final few months of the last quarter may see a boost in the number of new ANDAs.
