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 May shows that the OGD issued 43 full-approval actions (the lowest in any month thus far this fiscal year) but did issue 20 tentative approval actions, which is one more than the lowest (19, both in April and January).
After the stellar performance in April, one might expect a bit of a fall off as the push for the April numbers likely put a strain on the OGD approval machine. What I can tell you is that, in the first four days in June, the OGD had already issued 19 full approvals and 2 tentative approvals, which is a good start for the month.
We will report on the official May 2026 numbers as soon as the Generic Drugs Program Monthly and Quarterly Activities Report is published.
