The climb back to what we have come to see as the new normal for approvals continued in April. The unofficial April approval numbers obtained through the daily approvals and FDA all approvals databases (here and here) lists 62 full approvals and 9 tentative approvals. This comes after a January low of 25 approvals, February’s 32 and March’s jump to 57. The first three months of FY 2018 saw 87, 84, and 78 approvals, respectively.
We know the elemental impurities issue is being resolved both internally at FDA as data from firms is being reviewed, and externally in industry as firms get on board with supplying the required data, and this factors as a big part of the recovery in approvals. April 17th was a red-letter day when 14 ANDAs received full approval, and the last two business days of April generated 9 additional approvals. Hopefully, the trend will continue until we see close to or over 100 total approval action a month.
The official numbers will be out in a few days and we will report on them then. There are usually a few approvals that take time to work their way onto the approval databases, so we may see a few more that will likely push the totals higher. We will look at trends for approvals and receipts in that upcoming post as we will have 7 months of approval and receipt data at that time.
