May was a good month for the OGD in terms of approval actions and a few other statistical parameters. The OGD issued 71 final-approval actions and 13 tentative-approval actions in May 2024. While I was off in my estimation of unofficial actions by one on the approvals (72) and tentative approvals (12) (see the blog on May unofficial approval actions here), the total approval actions were still 84, which is the highest monthly total thus far this fiscal year. Great job, OGD! With eight months of FY 2024 officially in the books, given the current approval trends, it appears that the OGD will be heading for about 680 full approvals this fiscal year, a low since FY 2021 when there were 679.

Of the 71 approvals, twelve were for first-time generics, but only seven (9.8%) were first-cycle approvals, which is, percentage-wise, the lowest number we have seen for first-cycle approvals in a long time. Of the thirteen tentative approval actions, two (15%) were first-cycle actions.

As far as Complete Response Letters (CRLs), the OGD issued only 84, the lowest number since July 2017 when the OGD issued 82. On the brighter side, the OGD issued no refuse-to-receive letters in May! There were 68 new ANDAs acknowledged by the OGD in May, and there were 130 Prior Approval Supplements (PASs) approved in this reporting period.

Information requests continued in the 300-range with 360 being issued (217 for original ANDAs and 143 for supplements). Discipline review letters hit a high for FY 2024 at 233.

On the receiving end of the workload, the OGD received 52 new ANDAs in May. Projections based on the official numbers so far this fiscal year (through May) would indicate that the OGD will see a full fiscal-year total of 707 new ANDAs in FY 2024. We would have to go all the way back to FY 2015 to see a lower number (539). This is bad news for several reasons:

  • As the number of ANDAs decrease, the GDUFA fees for submission of new ANDAs will likely increase. The OGD is working to establish the FY 2025 ANDA submission fees now so be ready to plan accordingly.
  • ANDAs and the resultant post-approval work represent the majority of the OGD’s workload. In the government, as workload decreases, resources may need to be reallocated. With gains in efficiency in the review process and ANDA submissions below the 900 to 1,300-range, what do you think may happen?
  • As the market for biosimilars and complex generics produces greater revenue and as expenses for submissions increase, the potential for small-molecule non-complex generics becomes less attractive. This could further drive down ANDA submissions as firms look to concentrate on high-value targets rather than the fifth or sixth ANDA for a particular product.

Supplement submissions continue to be brisk with 1,058 (894 CBEs and 164 PASs) submitted in this reporting period. Controlled correspondences continue on pace with 301 submitted in May.

Looking at the OGD workload calculus, the number of pending ANDAs awaiting Agency action appears to be remaining fairly constant, standing now at 1,486, a slight uptick since last month. The number of ANDAs awaiting sponsor action took a bit of a tumble from previous months to 2,006 (498 ANDAs in tentative approval status and 1,508 awaiting complete responses).

In my opinion, we need to keep a close eye on ANDA submissions going forward as this is the bread and butter of the ANDA workload. Maintaining a steady state of submissions and approvals is key; if the numbers keep declining, we could see some Agency response relative to resource allocation. Also, keep an eye on how the current downturn in submissions will impact GDUFA fees! Please see here for the most recent full ANDA statistical report to see whether you have a different view of my concerns.