Hard to believe that it’s August 20, 2024 already, with just a little over one month until the end of the FDA’s 2024 Fiscal Year (FY). Time flies when you’re having fun! For today’s peek at approvals, I’m only reporting those through August 15th to increase the accuracy of the figures as the OGD is sometimes two or three days late in reporting the daily approval actions. Today’s peek is a little strange. What makes this report strange? Well, there are three reported approvals that appear to be for the second strengths of products previously approved under the same ANDA numbers. This usually indicates that, while one strength was previously permitted to be approved legally, the additional strength may have had its approval delayed due to an existing exclusivity of one form or another that blocked approval at the same time as the first strength, or there may have been a patent issue that impacted approval. So, the numbers reported, while representing actual approval actions, may not be reported in the FDA’s final number of total ANDAs approved. While we have seen this time and time again, I thought that it would be important refresh your memory on this issue because the number of approval actions may ultimately be higher than in the OGD’s final report of approved ANDAs for the full FY. Keep that in the back of your mind when looking at the final approval numbers for FY 2024. For example, you can identify such ANDAs in the Daily Approvals (here) or All Approvals Report (here) by the designation of Orig-2 or Orig-3, which indicates that they are the second or third strength approvals in a single ANDA when not approved on the same day.
Anyway, through August 15th, the OGD has posted thirty-two full-approval actions as well as eight tentative-approval actions. August started out strong but seems to have slowed down over the last four or five days. A total of forty approval actions isn’t bad at this time in the month but some big numbers in the second half of August would be welcome! It is going to be a while until we have a full view of original new ANDA receipts and approvals for the full FY so we will venture some estimates once we have the unofficial approval actions after the end of September; we will need to wait for the official receipts of new ANDAs until a month or two into FY 2025 when the final numbers appear in the Generic Drugs Program Monthly and Quarterly Activities Report (here).
