After a bit of a backlog dealing with the previous month’s postings, the May FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report was released just about when one would expect. So, let’s jump right into the numbers!
The OGD fully approved 64 ANDAs in May and tentatively approved 31 ANDAs for a total of 95 approvals. The number of original ANDAs approved was about five less than we had stated in our unofficial May actions post, which can be attributed to the fact that five of the ANDAs were second approvals for previously approved strengths of the same ANDA. Remember that approval actions (upon which our unofficial totals are based) come from the daily approval logs (see our previous post on May approval actions here). However, the number of ANDAs reported by the OGD in the daily reports are different than the number of reported ANDA approvals where strengths approved at different times under the same ANDA are folded back into a single ANDA approval for the purposes of the monthly statistical report.
Of the 64 full approvals, 17 were for first-time generics and 9 (14%) were first-cycle approvals. 12 of the 64 came from what are termed “imminent approvals” (ANDAs that had their user-fee goal dates “extended” to permit approval in the current application review cycle under a provision in the GDUFA commitment letter). Of the 31 tentative approvals, 8 (25.8%) were approved in the first-cycle review, with 7 of the tentative approvals being classified as imminent approvals.
The OGD issued 115 complete response letters in May, along with 3 refuse-to-receive letters, and acknowledged the receipt of 81 new ANDAs.
On the supplemental side of the house, the Agency approved 115 prior approval supplements (PASs) and refused-to-receive 5 supplements (which represents the highest number of PASs to receive an RTR letter in a single month since this metric was first added to the statistical report in FY 2018). Most fiscal years reported since then had only 2 to 8 for the entire year. This fiscal year year through May, there have been a total of 11 RTRs issued for supplements. This suggests that firms may need to take a closer look at their PAS submissions to ensure that they are complete and acceptable for review at the time they are submitted.
The OGD issued 414 information requests (225 for original ANDAs and 189 for supplemental submissions). The Agency also issued 123 discipline review letters.
As a measure of the OGD’s workload, the number of ANDAs awaiting FDA action dropped to a new, historic low of 1,289 (down 74 applications from the previous month). This is likely due to the low number of new ANDA receipts, which we will discuss below. ANDAs awaiting applicant action rose to 1,981, comprised of 557 tentative approvals waiting for applicants to respond and 1,424 outstanding complete response letters.
Now for the continuing bad news! The OGD received only 36 new ANDAs in May, which continued the trend of lower-than-average submission rates from previous fiscal years. At this point, the OGD has received only 357 new ANDAs in the first eight months of the fiscal year. If this rate continues, the OGD will likely receive only 536 ANDAs for the full year. This would be about 200 less than in the previous fiscal year. We’ll have to hope for a big September full of submissions, which could occur if the User Fee rate for ANDA submissions increases substantially beginning on October 1, 2025 for FY 2026. The new rates are typically announced in early August.
Amendments to original ANDAs have also slacked off, with only 122 being received in May (the lowest number in any month thus far this fiscal year). Of the 122 amendments, 38 were classified as major, 41 as minor, and 43 as unsolicited. Supplements continue strong with 967 receipts (800 for CBEs and 167 for PASs). In addition, controlled correspondence receipts were the highest for this fiscal year at 384. This could reflect a worry about new staff making decisions.
We continue to worry about the low number of new ANDAs being submitted for a few reasons:
- The lower number of ANDAs may mean higher ANDA application user fees.
- If the OGD workload decreases, it may have an impact on staffing levels, which are currently at their lowest point, I believe, since GDUFA’s arrival on the scene.
- Manufacturers shifting to complex generics and biosimilars could result in a void in firms willing to submit the simpler small-molecule ANDAs, leading to even more erosion in the ANDA submission rate.
Anyway, you can find the full statistical report for FY 2025 thus far here.
