With the first half of the month in the books and postings up through April 17, 2024, the OGD has issued thirty full-approval actions and seven tentative-approval actions. At this rate, it is possible that the OGD will hit or break sixty full-approval actions in April. This could be the first month that the OGD goes over sixty final approval actions in FY 2024, with the previous high being fifty-seven in October 2023 (the first month of FY 2024).

As noted previously, we are keeping a close eye on approval actions and ANDA submissions based on the lower numbers that we’ve been seeing in the last few months. If you have any thoughts on this issue, we want to hear from you! Please send them to r.pollock@lachmanconsultants.com.