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 […]
This month we will pat ourselves on the back as we captured the correct number of approval and tentative approval actions in our calculation of the unofficial numbers in our post here. We were more patient when looking at the February data from the daily approval page (which must be pieced together because it only […]
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 […]
Thus far, the Office of Generic Drugs (OGD) has issued a total of 32 full-approval actions and 7 tentative-approval actions for a total of 39 approval actions through March 21st. Unless there is considerable upward action on approvals through the end of the month, it is likely that March will be the lowest month for […]
A month and half after the close of the January books, we now get a look at the output and incoming workload of the Office of Generic Drugs for January 2024, the fourth month of Fiscal Year (FY) 2024. I will provide some of the highlights of the Generic Drugs Program Monthly Report, but you […]
The OGD’s approval actions for the month (at least those posted by March 5, 2024) are in line with the first four months of this fiscal year. There were 52 full approval actions and 11 tentative approval actions for a total of 63 approval actions. While we have not seen January’s official statistics yet, the […]
Based on approvals posted through February 16, 2024, the OGD has issued 28 full-approval actions and 5 tentative-approval actions so far in the month of February. Given that February is a short month to start with and has one federal holiday, we may get additional help as it’s a leap year and the additional day may […]
Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions. Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received. The OGD officially issued 53 approval actions in […]
January 2024 approval actions show that the FDA is moving in the right direction. The OGD unofficially issued 55 full-approval actions as well as 19 tentative approval actions for a total of 74 approval actions, a significant jump from December’s unofficial total of 59 total approval actions (52 full and 7 tentative). We are waiting […]
During her session yesterday at the AAM Annual Meeting, Iilun Murphy, M.D. provided additional details on the 2023 OGD metrics, indicating that there were 950 ANDAs approved and tentatively approved (782 and 172 approvals, respectively). Of the approvals, there were 90 first generics, along with 83 generics with Competitive Generic Therapy Designation, and 111 complex […]
