We are coming up to the end of another Fiscal Year and the OGD has just 2 months of official stats to report. Here is what Happened in July.
OGD approved 68 new ANDAs and issued 18 tentative approval actions in July. Of the 68 newly approved ANDAs, 6 were for first-time generics and 11 (16.2%) were approved in the first review cycle. Of the 18 tentative approvals, 3 (16.7%) were acted upon in the first review cycle.
As for other OGD actions, there were 126 complete response letters issued, which represents the highest number in any month this FY. OGD issued only 1 refuse-to-receive letter. OGD issued only 39 acknowledgement letters, the second monthly lowest in FY 2026 thus far. There were 152 prior approval supplements approved, 457 information requests issued (243 for original ANDAs and 214 for supplements) and 168 discipline review letters issued.
As a measure of workload in-house and with industry, OGD reports the number of pending ANDAs awaiting FDA action as well as the number of ANDAs awaiting sponsor action. There were 1,163 ANDAs awaiting FDA action and this represents the lowest number of pending ANDAs thus far this FY. As for those awaiting Sponsor action, the FDA reports there were 1841 ANDAs in industry’s court of which 573 are for outstanding tentative approvals and 1268 are for outstanding complete response letters.
On the receipt side of the house, OGD received only 36 ANDAs in July, another low month for ANDA receipts. However, they received 161 amendments to pending applications which is about right on the monthly average for this FY. Of the 161 amendments, 42 responded to major amendments and 46 responded to minor amendments and there were 73 unsolicited amendments received (the second highest number of unsolicited amendments were received in November 2025). Unsolicited amendments seem to be creeping up over the months, meaning the firms are making more changes to their applications that are not consistent with issues raised in the current review cycle.
OGD also received the highest number of supplemental applications this FY in July with a total of 1,293 (1,136 CBE supplements and 157 PAS supplements). Controlled correspondence receipt continued to be plentiful with 314 received in July.
Supplements seem to be driving the major workload in OGD with the number of originals dipping. No doubt there is plenty of additional work going on at OGD to support the review and approval process, however the concern over the lower number of ANDAs being submitted continues to be a worry.
We will soon be coming to the end of FY 2026 and will report on the full year statistics, likely sometime in late October or early November when the final tally for FY 2026 is reported by the Agency. I look forward to hopefully to see many of you at the AAM’s GRx-Biosims Conference to be held in Bethesda on November 2-4, 2026!
