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 […]
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 […]
Doug Long has become a fixture at AAM meetings, providing invaluable data on the drug industry on behalf of his employer, IQVIA. This presentation is always the highlight of AAM annual meetings. All attendees at this meeting make sure to have their seats nice and early to hear his state of the generic and biosimilars […]
Marty Shimer, Executive Director at Lachman Consultants, wrote a great post (here) about ANDA suitability petitions and the new GDUFA goal dates being assigned to them. His post gives us hope that the new system in place will provide some meaningful timelines for actions on ANDA suitability petitions used to make certain permissible changes from […]
Well, after a somewhat underwhelming start to FY 2024 (which began in October 2023), as reported here, it looks like things are picking up on the approval front for ANDAs. With approval postings through January 17th available today, the OGD has issued thirty-two full-approval actions and ten tentative-approval actions. This should bode well for a better January […]
