Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in our unofficial review of December’s available data (here). In that post, we recorded 68 full-approval actions and 16 TA actions for a total of 84 approval actions. However, in the official report (which can be viewed here), the OGD reported 67 full-approval actions, one less because one of the products received approval for a second strength and the OGD reports full approvals of additional strengths in the same application differently in its daily report, but only as a single approval for its monthly report. However, it also reported 25 TA actions for a total of 92 approval actions in December. It has been a while since we have seen a number like that! The difference in the number of TA actions can be attributed to late postings after the January 6th blog was published.

Of the 67 full approvals, 8 were first-time generic approvals and 11 (16.4%) were first-cycle approvals. Of the 25 TAs, only 3 (12%) were first-cycle approvals. The OGD also issued 118 Complete Response Letters, consistent with the first quarter of FY 2025 and the last six months of FY 2024, but much lower than the first six months of FY 2024 when the average monthly count was 135.

There were three Refuse-to-Receive letters issued in December, comprised of two standard applications and one priority application. The OGD acknowledged the shockingly low number of just 14 newly submitted ANDAs, which can be attributed to the low number of ANDAs submitted in the first two months of FY 2025 (14 and 18, respectively), but later we will provide the good news on this month’s new ANDA receipts.

The OGD approved 133 prior approval supplements, below last year’s monthly average of 142 approvals. In addition, the OGD issued 343 information requests in December, which is close to the monthly average of 358 for last fiscal year. Discipline Review letters fell to 100, which is the lowest number since February 2018 when 80 were issued.

Now for the good news on receipts! The OGD received 80 new ANDAs in December, a far cry from the anemic number of receipts reported for the first two months of this fiscal year. Please note that December is usually one of the two months with the largest number of ANDA receipts as it is the end of the calendar year (the other month is March, which is the end of the fiscal year in India). We may see a spike in new submissions in September as well if the new User Fees in October are higher than the previous fiscal year’s fees. Anyway, hopefully we will continue to see the number of original ANDAs submitted rise to a more customary figure. If they do not, we could be looking at a very down year for new submissions from the industry.

The OGD received the largest number of amendments for original applications in December, with 186 on the books. Of those, 65 were classified as major amendments, 72 as minor, and 49 as unsolicited. The number of supplements appears to be in the usual range at 875, with 712 being for changes-being-effected supplements and 163 being for prior approval supplements. [As a side note, Paul Schwartz, Division Director in the Office of Drug Product Quality, has announced that he will be retiring in March. Paul has been a great voice of reason throughout his entire 30+ year career at the FDA. I had the pleasure of working with Paul when I was at the FDA as well as in the industry after I left the Agency at the end of 1994. He will be greatly missed by his coworkers at the FDA and industry.]

Controlled correspondences are still hovering around 300, with 293 having been submitted in December.

Regarding FDA workload figures from applications, which are reported monthly, ANDAs pending FDA action stood at 1,438, which was a slight drop this month as the first two months of this fiscal year saw very low numbers of new ANDAs (as noted above). The number of ANDAs awaiting applicant action ticked up by only one in December to 1,929, comprised of 538 pending tentative approval and 1,391 complete responses awaiting industry response.

The first quarterly report of mean and median approval times for ANDAs in FY 2025 is provided in the table below:


Also, we are providing last fiscal year’s reporting on these statistical metrics below for comparative purposes:


As you can see, the numbers bounce around quite a bit from quarter to quarter. It is difficult to tell from them whether the OGD is improving on these metrics quarter after quarter so you can form your own impressions about what these figures actually mean. However, to me, at a first glance, it doesn’t appear that there is much improvement year after year. This is the third year that these metrics have been published, and you can also look back at the FY 2023 data here. We will continue to closely monitor the OGD metrics to keep you well informed.