As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals. What the heck does that mean? Well, let’s take an example from this month’s approval actions. On January 24, 2023, the OGD approved one fentanyl application; however, that single application had eight different strengths. This method of accounting in the reporting structure was instituted when the OGD decided to report multiple approval actions for a single ANDA with multiple strengths in its daily approval report to “get full credit for its work.” Clearly, approving an ANDA with multiple strengths takes significantly more work than approving an ANDA with a single strength because the amount of material that must be meticulously reviewed is multiplied by the number of strengths in the ANDA. However, in its monthly statistical report, all of the actions on the individual strengths are reported as one single application. And that is why we may seemingly report the numbers differently than what appears on the website.
This month, the OGD has fully approved fifty-three ANDAs that account for sixty-one full-approval actions (fifty-three plus the other seven strengths of the fentanyl ANDA and one additional strength of a mixed amphetamine ANDA) along with twenty-one tentative-approval actions. So, depending on whether you are speaking about how many individual applications the OGD approved, it is fifty-three full approvals and twenty-one tentative approvals, but if you are expressing this statistic in terms of approval actions, the number is sixty-one full-approval actions and twenty-one tentative-approval actions for a total of eighty-two approval actions on seventy-four ANDAs. Now that I have you completely confused, let’s just say that January was a good month for OGD approvals, no matter how you count them.
The real importance of the distinction comes when looking at the daily approvals for ANDAs on the Recent New and Generic Drug Approvals webpage (here) or the All Approvals and Tentative Approvals report (here) versus what you will see in the monthly Generic Drugs Program Monthly and Quarterly Activities Report (here) as this report lists only one application regardless of how many strengths are approved in a single ANDA.
Sorry to burden you with this exquisitely complex explanation, which we have provided in previous posts; however, for new readers who aren’t familiar with the reporting change that the OGD made a few years back, it may help in understanding any “unexplained” discrepancy in the various reports that the OGD formats.
