Over the Labor Day weekend, the FDA provided the latest full statistical report for the Office of Generic Drugs (here). The news continues to be good on the approvals front as the OGD issued sixty-nine full approval actions (one more than we captured in our unofficial peek (here) as the OGD snuck one by us). […]
Well summertime and its usual vacation schedule has not put a damper on ANDA approval actions and thus, I am happy to report that posting through August 16th reveal that OGD has issued 41 full approval actions and 7 tentative approval actions. If this pace keeps up for the rest of August, this will be […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023. There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023. OGD approved 76 new […]
After a slow start to the month, the steam is beginning to power up and halfway through July, OGD has issued 32 full approval and 9 tentative approval actions, so it looks like it should wind up being a good month if the last week’s proliferation of approvals continues. These figures represent postings of Approval […]
Another bit of good news for generic approvals! June unofficially recorded seventy‑five full‑approval actions and thirteen tentative‑approval actions for a total of eighty‑eight approval actions for the month. The seventy‑five full approvals represent the second highest number of full‑approval actions in a month thus far this FY, with the big daddy still being March with […]
Well, we’re just four months from the end of FY 2023 and the approval numbers still stand strong. In May, the OGD issued sixty‑three full‑approval actions and eighteen tentative‑approval actions for a total of eighty‑one approval actions. Of the sixty‑three full‑approval actions, six were first‑time generic approvals and thirteen (20.6%) were approved in the first cycle. […]
Well, June got off to a rousing start! In the first fifteen days, the OGD issued forty‑six full‑approval actions and nine tentative‑approval actions. This represents one of the best mid‑month totals (fifty‑five) that we’ve seen in a long time. If the month continues at this pace, we’re likely to see over 100 approval actions for […]
OGD published its official statistical report for April 2023 today (here) and we hit the nail on the head with our prediction of the number of full approval actions at 64 but we missed by one on the tentative approvals actions where we reported 11 (see previous post here), but there were actually 10 in […]
With the generic product approvals currently listed through May 15th on the All Approvals website (here), OGD has issued 30 full approval actions and 10 tentative approval actions for the month of May so far. Hopefully this will bode well for total approvals for the full month. We do have a major holiday coming up […]
