The official Generic Drugs Program Monthly and Quarterly Activities Report for December 2025 has been published and it covers the complete first quarter (October to December) of FY 2026. Let’s take it by the numbers.

In December 2025, the OGD approved 46 ANDAs, the lowest monthly total in the first three months of FY 2026. Of the 46 ANDAs approved, 6 were for first-time generics and 7 (15.2%) were first-cycle approvals. The OGD tentatively approved 23 ANDAs, of which 5 (21.7%) were tentatively approved in the first cycle. Each quarter (or more frequently if we see an anomaly), we like to project the estimated number of ANDA approvals expected during the full fiscal year. If the first quarter’s rate of ANDA approvals continues at its current level, we can expect about 632 ANDA approvals in FY 2026 (by comparison, FY 2025 saw 689 approvals), which would represent a third year in a row with a decline in ANDA approvals.

There were 88 complete response letters (CRLs) issued by the OGD, which is also the fewest in any month thus far this fiscal year. The OGD refused to receive just 1 ANDA in December, which is good news for industry. The OGD issued only 24 acknowledgement letters in December, less than 50% of those issued in each of the previous two months of FY 2026. This is likely a result of the FDA’s “0” receipts of any ANDAs during the first month and a half of the government shutdown, and indicative of the OGD catching up with acknowledgements during the later part of November.

Supplemental application approvals for December stood at 158, the most in any month so far this fiscal year. The OGD issued 495 information requests, broken down as 232 for original ANDAs and 263 for supplemental applications. This represents the highest number of information requests issued for the first three months of FY 2026, but only by 1 as the OGD issued 494 in October. However, discipline review letters (DRLs) tanked to 107, the lowest number for the fiscal year (the first two months saw 172 and 119 DRLs issued, respectively).

As a measure of the OGD’s overall workload, the OGD reports the numbers of ANDAs awaiting FDA action, which rose to 1,326 in December, the highest number of ANDAs in house in any month in the first quarter of FY 2026 (and increasing from 1,272 in November); this is likely due to larger number of ANDAs submitted in December (see below). The number of ANDAs awaiting applicant action dropped to 1,845, the lowest number as yet in FY 2026 (broken down as 585 for applications with tentative approvals and 1,260 for ANDAs with outstanding CRLs), down from 1,871 in the previous month.

There is better news on the receipt side of the house as the number of new ANDA submitted in December was 95. However, if we project the first-quarter’s rate of new ANDA submissions for the full fiscal year, the bad news is that the OGD would be expected to receive only 568 ANDAs, which would be yet another serious decline in ANDA submissions (last year saw only 600 new ANDA submissions). Please see yesterday’s blog post here, which describes some of the implications of declining ANDA submissions. Interestingly, of the 95 new ANDAs submitted in December, 19 (20%) were for complex products. Can you see where the industry is concentrating its resources now?

The OGD received 184 amendments to pending applications, broken down by amendment type as 56 major, 60 minor, and 68 unsolicited amendments.

Supplements reached a high of 922 submitted in December (the first-quarter monthly average was 855). The OGD also received the highest number of controlled correspondences thus far in FY 2026 with 361, the first month that industry has broken 300 thus far this fiscal year.

At the end of each quarter, the OGD calculates the mean and median times for approval and tentative approval of ANDAs. Looking at a comparison of first-quarter FY 2026 mean and median approval times with those of the first quarter of FY 2025 (see below):

While the mean and median approval times decreased for the first quarter of FY 2026, we see that the mean and median tentative approval times increased significantly. These numbers are very fluid from quarter to quarter as there are a number of factors that can dramatically influence approval times. It’s not easy to draw firm conclusions from the numbers as they have historically bounced around from quarter to quarter over the years since the OGD began reporting these approval times.

For additional information and additional statistics please see the full Generic Drugs Program Monthly and Quarterly Activities Report (here). We’ll be back when the January statistics are finalized, likely around the end of February!