June was a hot month for most of the East Coast, and it was a hot month for ANDA approval actions too (albeit but just a tad cooler than May’s numbers). OGD managed to issue 76 full approval actions and 17 tentative approval actions for a total of 93 approval actions in June. The 76 […]
The FDA approved the first generic of Baloxavir Marboxil tablets 40 mg and 80 mg for Norwich Pharmaceuticals Inc., on June 17, 2026. It is the generic equivalent of Genentech’s Xofulza approved for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 […]
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 […]
Here we are, in the middle of June already! Where does the time go? If you have a few minutes away from scanning the World Cup results, let’s see how the OGD is doing, as far as approvals go, during the first fifteen days of the month. As of June 15th, the OGD has issued […]
On June 4th, the FDA issued a guidance document titled Certain Postapproval Requirements and Resources for ANDAs (here) in an effort to streamline ANDA approval letters. Previously, each ANDA approval letter had certain information regarding standard or specific post-approval requirements. Instead, the new guidance document provides a listing of the standard requirements and responsibilities of […]
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 […]
On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]
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. […]
