The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number.  The OGD also acknowledged sixty‑two ANDAs in March.

Other metrics of note include:

  • Ten (or 15.9%) of the sixty‑three full‑approval actions were approved in the first review cycle, but none of the eighteen tentative‑approval actions were first‑cycle approvals.
  • Information requests (IR) hit a high for this FY at 466 and, as a matter of fact, this was the highest number of IRs issued since the OGD began reporting that metric in FY 2018.
  • Discipline review letters (DRL) also hit a high of 243 for FY 2022.
  • The number of amendments received by the OGD also topped the FY chart at 261, a significantly higher number than the FY 2022 monthly average of 221.
  • Changes being effected (CBE) supplements pushed back over the 700‑mark with 748 submitted (the second highest number in a month behind October, when 811 were submitted) and prior approval supplements hit a FY high of 138.
  • Controlled correspondences also hit a FY high of 347, indicating that the industry is still fearful of not having an OGD answer in hand before embarking on anything out of the ordinary.

The full report of monthly stats can be found here.

I do have a concern about the April approval numbers as there has only been a single ANDA approval action or tentative‑approval action posted in the daily approval list or FDA All Approval list since April 20, 2022.  This is highly unusual and hopefully the explanation is simply an issue with posting the last ten days of figures for April as the numbers reported thus far would stand at thirty‑three full‑approval actions and three tentative‑approval actions for a total‑approval action number that would be quite concerning to industry for sure.  Yikes!  The OGD’s reporting can sometimes be a few days behind but I have never seen this long a period with no ANDA approval‑action postings in the thirteen years I have been writing the Lachman blog!