April showers bring May flowers, as the saying goes. Well, April thus far has not showered down approvals as, halfway through the month, the OGD stands at twenty‑one full‑approval actions and three tentative‑approval actions. If the trend continues through the end of the month, we could be heading for a month with less than fifty […]
March ANDA full‑approval actions (reported thus far) sit at sixty‑three, the second highest total this fiscal year (FY), eclipsed only by the sixty‑seven full‑approval actions in November. That’s the good news! The OGD only issued four tentative‑approval (TA) actions in March, the lowest number this FY (the previous range was eight in November to twenty‑two […]
I believe everyone likes seeing the progress of ANDA approval actions, and hold that as the primary measure of success of OGD. I know that has been the case ever since Hatch-Waxman was implemented in November of 1984. So I continue to track this metric very closely and at least through the morning of March […]
With ANDA reporting through January 21, 2022, the OGD has issued thirty full‑approval actions and eight tentative‑approval actions for a total of thirty‑eight approval actions issued so far this month. With only six more reporting days remaining, these unofficial numbers, gathered from the FDA All Approvals list here, it looks like the total approval actions […]
Well, OGD is back over the 70 mark for total number of approval actions in a single month, with what appear to be at least 72-66 full approval actions and six (6) tentative approval actions reported, going by the numbers posted at 11 AM EST December 3 on FDA’s website. The last time OGD had […]
Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions. November has at least […]
Well, the first month of FY 2022 appears to be an improvement over the last month of FY 2021, which was reported as forty-nine total approval actions, as the OGD hit an unofficial total of sixty-two in October 2021. The total is broken down into fifty full-approval actions and twelve tentative-approval actions. Usually, a few additional […]
Well, September saw not only a low for this fiscal year (FY) of forty‑two total approval actions (both full (thirty‑nine) and tentative (three) approvals), but you have to go all the way back to February 2018 to find a lower number of total approval actions (thirty-seven). And, remember, that number was caused by the approval […]
The FDA has updated its first-generic approvals list for calendar year 2021 (here). The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals. As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]
As of the posting on September 3, 2021, the FDA’s “All Approvals” database (here) listed fifty-five full‑approval actions and eight tentative-approval actions for August. While we know that these numbers can creep up with a couple of stragglers being reported a bit late, the good news is that the OGD hit a total of at […]
