The OGD has been a bit slow in posting approval actions this month. The total number posted through July 15th are 24 full-approval actions and 2 tentative-approval actions. There were none posted yet for July 16th and 17th, but this may just be a delay in processing the actions through the system. Regardless, with half […]
After a bit of a backlog dealing with the previous month’s postings, the May FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report was released just about when one would expect. So, let’s jump right into the numbers! The OGD fully approved 64 ANDAs in May and tentatively approved 31 ANDAs for a total of […]
While it has been June gloom in California, when the gray marine layer forms over the Pacific Ocean and it stays cloudy on the beaches (especially in the mornings) for most of the month, it looks like the coast was clear in Bethesda, Maryland as the OGD unofficially issued 66 full-approval actions and 20 tentative-approval […]
Well, we are halfway through June and it’s time to take a look at the unofficial Approval Actions. Through June 17, 2025 (note that the OGD is usually a day or two behind on approval postings), there were 29 full-approval actions and 12 tentative-approval actions posted on Drugs@FDA: FDA-Approved Drugs (here). What this means is, […]
Well, another good month for approval actions at the OGD as it keeps the approval train in high gear. There were 69 ANDA full-approval actions in May. Please note that three of the full-approval actions were approvals of second strengths for previously approved ANDAs that were likely the result of delayed approval due to patent […]
Well I don’t know whether it was my continued questioning of the whereabouts of the last three months’ report figures, although I highly doubt it, or the rehiring of some of those policy people previously RIFed that finally gave the OGD enough bandwidth to get to the many things on its plate, with this report […]
In what has been a rather strange pattern of ANDA approval actions in May, the OGD has issued 36 full-approval actions and 5 tentative-approval actions in the first fifteen days of the month, which is a good result. However, the daily approval pattern seems a bit strange. On May 2nd, the OGD issued 9 full-approval […]
While we were able to piece together the April 2025 unofficial approval picture, we need to note that it has now been over three months since any official statistics from the Generic Drugs Program Monthly and Quarterly Activities Report have been published publicly (see here). This is a bit discouraging, but not totally unexpected, after […]
With the first (albeit unofficial) count of ANDA approval actions since the layoffs at the OGD, the future does not appear bleak. At least not yet! The postings through April 16th for approval actions show that the OGD has issued 43 full-approval actions and five tentative-approval actions for a mid-month total of 48 approval actions, which […]
On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]
