The unofficial approval-action numbers for ANDAs improved a bit from last month’s seventy, with the OGD hitting a total of full- and tentative-approval actions of seventy-eight. This breaks down to seventy‑two full-approval actions and six tentative-approval actions. These numbers are as of the morning of March 5, 2021 from the FDA’s All Approvals list (here). […]
As you know, we try to track the ANDA approval actions and report on other OGD metrics as closely and as early as we can to try to give you the most current and most timely information. The one thing we have found that the generic industry, as a whole, is most interested in are […]
We are two-thirds through the reporting workdays for the month of January 2021 and OGD has reported 35 full approval actions and 4 tentative approval actions (total 39). If the pace of approvals does not pick up in the last 6 reporting days, we are set to have a total of full and tentative approval […]
Well, the holiday season may produce a “December to remember”, to quote a car manufacturer’s favorite tag line at this time of year. What we don’t know is will it be good to remember or not so much. December usually is one of the highest months for approval actions with the last three Decembers producing […]
The unofficial November totals for approval actions and tentative-approval actions for month two of FY 2021 dropped from a total of ninety-three to seventy-two. The seventy-two can be broken down into fifty-five full-approval actions and seventeen tentative-approval actions. As with every month, the totals may change a bit when the OGD reports its official numbers sometime […]
We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three. The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals. Good way to […]
Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months. That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions. Why do […]
With just 6 days until Halloween, what does the prospect for Trick or Treat look like in the ANDA approval candy basket? So far, the reporting of approval actions looks like treats will be in the bag. As of approval actions reported through October 22, 2021 OGD has issued 50 full approval actions and 6 […]
The end of the FY saw a bump back up to the 80’s for number of total approvals with 73 “line item” full approval actions and 10 tentative approval actions. What the heck is a “line item” approval action, you may ask? Well, we noticed in September (or perhaps we just missed it in previous […]
According to the unofficial August numbers derived from the FDA’s All Approvals list (here), the Office of Generic Drugs issued 58 full approval (AP) actions and 10 tentative approval (TA) actions during the month of August 2020. The number of APs and TAs are both the lowest number of approval actions in the past 7 […]
