The approval metrics look very similar to previous months during this fiscal year but there is good news on the number of new original ANDAs received. Let’s take a look!

The OGD approved 56 ANDAs in March, 7 of which were first-time generics and 17 (30%) were approved in the first cycle. This 30% represents a dramatic increase in first-cycle approvals, at least for this month. Hopefully it represents the start of a trend! The OGD also issued 31 tentative-approval actions in March, and 4 (13%) were approved in the first cycle. The good news is that the estimated number of ANDA approvals for full FY 2026 has bumped up to 674. Also, if the month of April finishes out like it started (you may have read the good news in our Mid-April 2026 Approvals Action post (here)), we will likely be able to report a higher projected average number of approvals per month for FY 2026.

Action on Complete Responses Letters (CRLs) issued hit the lowest this fiscal year at 80. In addition, the OGD acknowledged 40 new ANDAs in March.

There were 150 Prior Approval Supplements (PASs) that were approved. The OGD also issued 410 information requests to sponsors (221 for originals and 189 for supplements). The number of discipline review letters issued soared to 274 (the previous high for FY 2026 thus far was 172).

The OGD’s current in-house workload figures for ANDA applications are reported as Pending ANDAs Awaiting FDA Action, and these jumped from 1,233 to 1,277, in part due to the higher number of ANDAs received. ANDAs awaiting applicant action dropped from 1,861 to 1,833, broken down as 585 outstanding tentative approvals and 1,248 CRLs.

Now, some good news for the receipt side of the house! The OGD received 107 new ANDAs in March, likely propelled by the end of India’s fiscal year when submissions from Indian pharma companies are typically high. Of the 107 new ANDAs received, 26 (24.3%) were for products classified by the Agency as complex. Halfway through the fiscal year, the six-month total of ANDAs received now stands at 309 so we can anticipate 618 ANDA for the full fiscal year. This would be just 18 more than the number received in FY 2025, which was the first year with a substantial ANDA decline.

The OGD received 184 amendments to ANDAs (with 56 classified as major amendments, 70 as minor and 58 as unsolicited amendments). Yet again, the number of ANDA supplements submitted seems to provide a more substantive workload for the OGD with 981 (858 Changes Being Effected (CBEs) and 123 PASs) received in March. 981 represents the highest number of supplements received in a month thus far this fiscal year. Controlled correspondences received by the FDA hit the mid-300s for the second month in a row, with March seeing 359.

March represents the close of the second quarter of FY 2026 and with that comes a calculation of the mean and median approval (both full and tentative) times for ANDAs; see the chart below.

As is evident from the data, for full approvals, both mean and median approval times dropped, while for tentative approvals, the mean and median times both increased. As we have explained previously, there are many factors that play into these calculations, which may be impacted by the number of cycles that ANDAs go through, the speed at which ANDA applicants respond to CRLs, patent or exclusivity issues for tentative approvals, just to name a few. It is difficult to draw any clear conclusions from the changes in each quarter. If you look back over the past three to five fiscal years, the reported mean and median times clearly fluctuate significantly from year to year, which may be conditioned by the overall cohort year in which the original applications were received, the quality of the application, and when it was obviously ultimately approved.

Anyway, that’s it for now. For all of you generics statistical junkies, you can find the full report here.