Yesterday, the Office of Generic Drugs published the November addition to its FY 2024 Generic Drugs Program Monthly and Quarterly Activities Report (here). Officially, the OGD issued 51 final ANDA approval actions and 17 tentative-approval actions for a total of 68 approval actions.
Of the 51 final approval actions, four were for first-time generics and six (11.8%) were first-cycle approvals. With the first two months of full approvals in, there is not too much we can predict with any reliability but we can say that, if the rate of approvals remains the same throughout the rest of the fiscal year, then we are likely to see only 648 ANDA full approvals this FY, which would be the lowest since FY 2016 when the OGD approved 641 new ANDAs. Early GDUFA years, from 2013 through 2015 (the first three years of GDUFA), saw approvals ranging from 409 to 490, and, since then, only two fiscal years have been in the 600-range. I am certainly hoping that future months will show an improvement. As far as tentative approvals go, of the seventeen TA actions, none were approved in the first cycle, also a bit of a troubling sign.
As far as other FDA actions, Complete Response Letters dropped to 137, still above the FY 2023 monthly average of 123, but well below the FY 2022 monthly average of 151. The OGD issued just two Refuse-to-Receive letters, which is good news, and acknowledged 49 new ANDAs. Approval of Prior Approval Supplements (PASs) dropped from 203 in October 2023 to 108 in November.
Information Requests popped up to a healthy 395 in November, considerably higher than the 324 monthly average seen in FY 2023. Discipline Review Letters dropped to 162 (the FY 2023 monthly average was 204).
On the receipt side of the house, the OGD received 51 ANDA in November (the FY 2023 average was 61 per month) and, given that the OGD received only 26 ANDA in the first month of FY 2024, if this trend continues, it could be back to receiving fewer than 500 ANDA this fiscal year. This could represent a significant reduction in the OGD’s workload.
Receipt of ANDA amendments for November dropped from the previous month’s 211 to 194 (the FY 2023 monthly average was 221). Total supplements received is still hovering around the 1,000-mark with November’s influx of 968, with 832 being for Changes Being Effected supplements and 135 being for PASs. As far as Controlled Correspondences received, this is the second month in a row that the numbers were under 300, with 264 and 257 respectively for October and November.
ANDAs pending with the OGD dropped for the seventh month in a row from 1,647, and now stand at 1,417. On the other hand, ANDAs pending with sponsors have shown a fairly steady increase over the past four months, starting at 2,018 in August 2023 and standing at 2,104 in November 2023. So, while the OGD is lowering its workload in the new ANDA arena, industry appears to be falling a bit behind in responding to the FDA’s CRLs.
See the link at the top of this blog to explore all of the statistics that the OGD reports, and be certain to look at its next report for December, when it will present the median and mean approval times for full approvals and tentative approvals for the first quarter of FY 2024.
