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 […]
Presentations for the Generic Drug Forum, which was held in person and virtually on April 8-9, provided a look at the Office of Generic Drugs’ compliance with Fiscal Year (FY) 2024 User Fee goals for review of applications and supplemental applications. The OGD has met all of its review objectives from the GDUFA commitment letter for […]
As we approach the last week in March, we now have one-third of FY 2025 behind us. January’s ANDA approval numbers continue to look good, as we discussed in our February 6, 2025 post on the unofficial January approval actions (here). Another month with 90 total approval actions is good news for industry. The monthly total is […]
The old saying “March comes in like a lion and goes out like a lamb” might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval […]
