The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they are.
The OGD issued 42 full approvals (1 less than the 43 approval actions we predicted as there was a single ANDA approval for the second strength on a previously approved ANDA). Of the 42 ANDA approvals, 6 (14%) were for first-time generics, 11 (25.6%) were approved in the first review cycle, and 2 (5%) resulted from imminent actions. At the current rate of approval, the OGD could reach about 693 by the end of the fiscal year (FY). In addition, the OGD issued 21 tentative approvals, of which 8 (38%) were approved in the first cycle. First-cycle approvals, both full and tentative, seem to be increasing over the last month or two, but we’ll reserve final judgment on that trend until the end of the FY.
On other workload actions, the OGD issued 77 complete response letters (CRLs), the fewest thus far this FY. Notably, no refuse-to-receive (RTRs) letters were reported as issued for new ANDAs in May, and so far this FY only 10 RTRs have been issued. That seems pretty good to me!
May also saw the OGD acknowledge 86 new ANDAs, which probably include a remnant of the 107 ANDAs received in March 2026, some of which are likely still being processed. The number of prior approval supplements (PASs) approved for the month was 116, only 2 more than the low of 114 in any previous month this FY. Information requests (IRs) jumped back into the 400s with the OGD issuing 425 IRs in May. The IRs can be broken down as 246 for originals and 179 for supplemental applications. Discipline review letters issued totaled 184, about a middle-of-the-pack average for the FY.
As a measure of the OGD’s in-house and pending workload figures, the number of pending ANDAs awaiting FDA action jumped by 16 to 1,316, while the number of ANDAs awaiting applicant action went down 13 to 1,770. The ANDAs awaiting applicant actions represent 566 tentatively approved ANDAs and 1,204 CRLs that are in the applicant’s court.
On the receipts side of the house, the OGD received 58 new ANDAs in May, which would “straight line” to a FY total of 624 if monthly submissions continue at the current pace. However, we anticipate, if ANDA User Fees are substantially increased for FY 2027, that we could see a higher number of ANDAs submitted in a potential September rush, prior to October 1, 2026 when the new, yet-to-be-announced rates are set to take effect.
The OGD also received 138 amendments, of which 46 were classified as major, 47 as minor, and 45 as unsolicited amendments. In addition, the OGD received 948 supplements (806 Changes Being Effected (CBEs) and 142 PASs). This is just slightly above the monthly average of 936 supplements submitted in FY 2026 through May.
Controlled correspondences continued at the same pace that we’ve seen in the previous months, in the low to mid-300 range, with 321 submitted in May. I can tell you that more applicants are afraid to guess on an OGD requirement when there is even the slightest possibility that a reviewer may not agree with an applicant’s position. This is why applicants want most deviations or potential ambiguities in the OGD’s stance to be clarified with a response from the Agency rather than take a chance on receiving a refuse-to-receive letter or getting an unanticipated CRL based on a specific issue.
For all of you data geeks, you can find the full May Generic Drugs Program Monthly and Quarterly Activities Report at the link in the first paragraph. Enjoy!
