A sneak peek at the Office of Generic Drugs’ May 2024 approval actions should put a smile on the industry’s face as the OGD hit the highest number of total approval actions so far this FY in May. The OGD issued a total of 84 approval actions last month, consisting of 72 full-approval actions and 12 tentative-approval actions. The unofficial 72 full approvals posted was also the highest monthly total of full approval actions thus far for FY 2024, with the next highest being 65 in the previous month, April 2024.

With two stellar months in a row, is this becoming a new trend, or will it become an expectation? We will see whether the May numbers hold true when the official approval statistics are published (hopefully later this month). It is interesting to note that there were only two business days in May when no approvals or tentative approvals were issued, and those days were May 30th and 31st. Guess the OGD ran out of steam at the end of the month (so to speak)!

Could it be that the April first-cycle approval percentage of 29% for full approvals carried over into May? It is possible! Let us know your thoughts.