Today, the FDA posted its August 2025 monthly statistical report, and with FY 2025 ending on September 30, 2025, we’re only one update away from the official numbers for the full fiscal year.

The August update indicates that the OGD did, as previously reported, fully approve 47 new ANDAs and (at OGD official count for the monthly report) issued 13 tentative approvals. Of the 47 full approvals, 8 were for first-time generics and 9 (19.1%) were approved in the first review cycle. Of the 13 tentative approvals, 4 (30.8%) were approved in the first review cycle.

The OGD issued only 82 complete response letters, the lowest number in any month during FY 2025 with only September left to report. In August, the OGD issued only a single refuse-to-receive letter and 47 new ANDA acknowledgement letters, which is good news!

There were 102 prior approval supplements approved (the second lowest in a month for FY 2025), and the OGD issued 439 information requests (224 for original ANDAs and 215 for supplemental applications). In addition, there were 153 discipline review letters issued by the OGD in August.

The FDA reports the number of ANDAs awaiting FDA action as a partial measure of the OGD’s backlog of work. This is the first month in the past three where the number of ANDAs awaiting FDA action increased, going from 1,238 to 1,259. On the other hand, the number of ANDAs awaiting applicant action (a measure of outstanding workload) dropped from 1,967 to 1,924 applications (559 tentatively approved applications awaiting final requests for approval by the applicants, and 1,365 outstanding complete response letters). The drop cannot easily be explained from the statistics presented in the report as the number of amendments received by the OGD was about average and there weren’t a lot of unapproved ANDAs withdrawn, nor were there a significant number of ANDAs approved. I guess one could just say that it is what it is and leave it at that!

On the receipt side of the ledger, the OGD received only 36 new ANDAs in August. With the ANDA receipt total for the first eleven months standing at 486, it appears unlikely that the OGD will break 600 new ANDA receipts this fiscal year. An interesting note is that 7 (19.4) of the 36 new ANDAs received were for complex products. The OGD also received 172 amendments in August (47 were classified as major, 65 as minor, and 60 were unsolicited amendments).

August did have the largest number of supplemental submissions for the fiscal year with 1,317, of which 1,128 were for changes being effected supplements and 189 being prior approval supplements.

Controlled correspondences (CCs) took a tumble to 222, which clocked in as the second lowest number of monthly submissions of CCs thus far this fiscal year. The FY 2025 eleven-month average of CCs received currently stands at 323. Could this decrease in CCs be attributed to fewer ANDAs being submitted, or is it just a one-off month?

For those of you who are real statistics junkies, please take some time to view the full August report, which includes other interesting statistics, here.