As we noted in the May mid-month blog report (here), the May approval action total was likely to be much lower than April’s high for the fiscal year of 85 full and 19 tentative approval actions. Well, May’s numbers are indeed lower, and by quite a bit. The unofficial peek at the monthly figures in […]
Through May 15, 2026, the OGD reports 26 full approval actions and 11 tentative approval actions. Given the number of actions in the first half of the month, May approval actions will likely fall well behind the April figures, even if the approval pace picks up. So, with 37 total approval actions thus far in May, […]
We previously noted that April would likely be a good month for OGD approvals, and it was! The OGD approved 85 ANDAs, of which 41were first-time generics; however, only 10 (11.7%) were first-cycle approvals. This low percentage of first-cycle approvals is likely because of the large number of single-entity and combination dapagliflozin products that were approved […]
While April showers may bring May flowers, the number of unofficial April ANDA approvals sure is a welcome event. April saw full approval of 87 ANDAs, the highest number since August 2023 when the FDA approved 98. April’s total was bolstered by the 24 full approvals of dapagliflozin single entity and combination products on April 6th. […]
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 […]
The FDA has posted a total of 82 approval actions in March to date on the FDA All Approvals page. Of course, these numbers could change over the next few days as the posting of some applications is delayed. The OGD’s approval pace has been consistent over the past eighteen months. During March, the OGD […]
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, […]
February was a short month with a big number as the OGD issued 64 full-approval actions and 25 tentative-approval actions for a total of 89 approval actions. This represents both the highest number of approvals thus far this fiscal year and the most total approval actions since January 2025, when there were 90. With ANDA […]
We now have official statistics for one-third of FY 2026. While the number of full approvals hit a high (by one) for FY 2026, the number of new ANDA receipts in January were disappointing. Let’s take a look at the most significant statistical metrics for the current report. As far as FDA actions, the OGD fully approved […]
Well, here we are, just a tad over halfway through the shortest month of the year. That’s right, there are only twenty-eight days in February, and one of them is a holiday. This February there are only nineteen business days during which OGD approvals can occur. Today, we can report on approvals posted through February […]
