Official ANDA Approval Numbers, CRLs, and Original New ANDA receipts for July 2022 Reported

July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions.  In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here).  That darn additional TA was posted after our blog post (so close!).  So, the OGD hit over the seventy‑mark again (which seems to be its new sweet spot) with a total of both full‑approval and tentative‑approval actions of seventy‑eight.

Absent a big push for approvals in the last two months, based on the current rate of approvals, the OGD is likely to fully approve about 695 ANDAs and tentatively approve about 182 ANDAs in FY 2022.  Those numbers would be slightly higher than FY 2021 approval actions of 679 and 157, respectively.

As far as new ANDA receipts for July, the OGD received sixty and, thus, is poised to receive about 842 for the full fiscal year, up from 809 in FY 2021.  The delta between ANDA approvals and receipts in FY 2021 was 130 and, if the numbers hold for FY 2022, we project that delta will be 147; the gap has widened from twenty‑six in 2019, and has gone up in both FYs 2020 (128) and 2021 (130).

So, the backlog (or workload, as the OGD likes to call it) appears to be creeping up.  Is that important?  Well, it depends on the ultimate magnitude of the numbers and whether the delta continues to grow over the coming years.  The key to the OGD approving more ANDAs than it receives, I believe, will be dependent on how well the GDUFA III initiatives are at driving first‑cycle approvals.

The last official metric that the OGD has previewed from July 2022 is the number of complete response letters (CRLs) that it issued; that number for July was 171 (the second highest number issued this FY, behind only the 195 issued in January).  However, an interesting trend I noted is that the number of CRLs issued by the OGD has decreased in each of the last five years (see chart below).

Number of Complete Response Letters Issued by the OGD for the Last Five FYs

* Projected based on ten-month average

How does this play into workload, especially with the number of approvals not moving up correspondingly?  I am not sure, but I think it may be an issue to discuss at some point.

That’s my story for this month and I am sticking with it!