As the saying goes, March came in like a lion but went out like a lamb. The OGD issued only 48 full-approval actions and 13 tentative-approval actions for a total of 61. The beginning days of the month looked relatively strong but that kind of petered out towards the end of the month. The 48 full approvals represent the lowest number of full-approval actions thus far this fiscal year, as does the total of 61 full- and tentative-approvals for the months for which official numbers have been reported this FY. (We must note that official numbers for only four months, October 2023 to January 2024, have been reported so far.) Hopefully we will see official totals for February soon, but, as reported here, the unofficial numbers for February 2024 were only 52 full-approval actions and 11 tentative-approval actions, which is consistent with the data we have seen for each month this FY.
I am a bit surprised at the decrease in approval actions and am at loss for an explanation. I have voiced concerns about the number of approval actions as well as declining ANDA submissions in previous posts. Perhaps this is becoming the new normal. We should all keep an eye on this trend and perhaps the OGD will comment on this at one of its upcoming webinars.
