Last night, the FDA published the Generic Drugs Program Monthly and Quarterly Activities Report for February 2026 (here).  As has been the case lately, there is both good and bad news.  Let’s look at the highlights of the report.

First, let’s look at the approval metrics.  The OGD fully approved 64 ANDAs; of that number, 6 were for first-time generics, 18 (28%) were first-cycle approvals, and 13 came through the imminent-action enhancement that permits the OGD to extend a goal date when the application can be approved in a relatively short period of time without it being considered a goal date missed.  As far as tentative approval actions, the OGD issued 26, of which 4 (15.3%) were first-cycle approvals and 5 obtained approvals in the same cycle under the imminent-action enhancement.  The total of 90 approvals is, of course, good news, and the first-cycle approval rate of 28% for originals is also promising.

As far as other OGD output metrics, the Agency acknowledged 62 new ANDAs.  In addition, the OGD approved 142 prior approval supplements (the second most thus far this fiscal year behind 158 that were approved in January 2026).

The issuance of information requests (373) fell below 400 for the first time this fiscal year.  The high for FY 2026 thus far was in December when the OGD issued 495.  The issuance of 165 discipline review letters represents the second most in a month thus far this fiscal year.

The OGD workload statistics show a continued trend in lower numbers of ANDAs awaiting FDA action (1,233), likely attributed to the lower number of new original ANDAs being submitted (see further discussion on this issue below).  The number of ANDAs awaiting application action has been hovering around the mid- to high-1,800s for each of the first five months of FY 2026; there are 1,861 applications in the industry’s court awaiting responses, made up of 584 outstanding tentative approvals and 1,277 complete response letters.

Now, the continuing bad news story of FY 2026 is the number of new ANDAs being submitted.  In February, there were only 28 submitted, which is the fewest submitted in a month during which the FDA was accepting new application this fiscal year (see chart below).

Month FY 2026 October November December January February
Number of
ANDAs Submitted		 1* 46 95 32 28

* represents an application that should have been received in September

Based on the number of ANDAs submitted to date this fiscal year, and assuming the same rate of submission for the rest of FY 2026, we would expect about a total of 484 ANDAs to be received in FY 2026.  This number would be dwarfed by the 1,473 ANDAs received in FY 2014, the second year of the GDUFA era.  The continued decline in ANDAs submissions is indeed disturbing.  The decline is a result of a multitude of factors including, but not limited to, consolidation in the generic-drug industry, concentration by manufacturers on complex products that have will have a higher ROI, the shift in resource allocation to biosimilar opportunities, and shrinking margins on generic products.  Perhaps, with the pending patent cliff coming over the next two years, we’ll see a resurgence of ANDA submissions.  But at this point, it may be just a hope, and nowhere near an assurance!

Getting back to the input of factors of the OGD application workload, the OGD received 161 amendments to existing applications.  These 161 amendments are categorized as 62 major, 54 minor, and 45 unsolicited amendments.

The OGD continues to receive a substantive number of supplements for review.  In February, the OGD received a total of 866 supplements (about average for FY 2026), which breaks down as 742 CBE and 126 PAS.  The OGD also received 362 controlled correspondences, which is the most (by one) thus far this fiscal year.  The general uptick in controlled correspondence this fiscal year seems to suggest that sponsors are still hesitant to make independent decisions on unusual or even common issues without having a piece of paper from the OGD validating or giving the go ahead for its stated position.

Next month in the report, the OGD will provide its summary of mean and median approval times for the second full quarter of FY 2026.  We’ll be back then with the numbers!