Just 25 days before the end of Fiscal Year (FY) 2024, the official July statistics were just posted here.  The two biggest items of interest to industry from these monthly reports are usually the number of approval actions, as well as the number of ANDA receipts so, let’s get the important stuff out of the way first.

July 2024 saw the OGD issue 63 full approvals and 12 tentative approvals, which is what we predicted in our previous July unofficial approvals post (here).  The 63 full approvals were the third highest of the FY through July.  Of these 63 full approvals, 6 were for first-time generic approvals and 12 (19%) were first-cycle approvals.  The OGD seems to be stuck at between 15-20% first-cycle full approvals each month.  This number needs to improve as the game rules are set but the industry still believes that they are trying to hit a moving target with distinct types of questions from different reviewers impacting the number of cycles the ANDA must go through.  Are our readers in industry still experiencing what we also seem to be seeing?  Please let us know at r.pollock@lachmanconsultants.com.  Oh, and FYI, for NDAs, first-cycle approvals are in the range of 85-90%.  The OGD still has work to do!

New ANDA receipts in July totaled 47, of which 11 were classified as complex products.  The 47 ANDAs were the third lowest number submitted in any month, thus far, this FY.  Unless we hit a large number of new ANDAs in September, we are likely to see only about 681 ANDAs for the full FY.  The number of new ANDAs being submitted, in my opinion, has shown a dangerous decline over the past 10 years.  Maybe, the OGD will address this issue at the upcoming GRx-Biosims meeting in Bethesda in October.

Other FDA actions show the number of complete response letters at 119, just slightly below the 10-month average of 124.  Refuse-to-receive actions remain low at 4 for July (average of 2.2/month for 10 months).  The OGD did acknowledge 51 new ANDAs in July.  Also, there were 133 prior-approval supplements approved, slightly below the 10-month average of 143.5).

The number of information requests totaled 357 for July, with 204 sent to pending ANDAs and 153 sent to submitted supplements.  In addition, 170 discipline review letters were issued.  These numbers are in line with the 10-month averages.  The OGD received 1150 supplements of which 978 were for CBEs and 172 were for PAS supplements.

It is interesting to note that the OGD now reports on a number of newer GDUFA III meeting/telephone requests and the two most used enhancements (at least this FY) are the request for product-development meetings, which hit a high of 12 in July (10-month total of 71 requests) and the number of post-CRL clarification-only teleconferences, with a 10-month total of 60 requests.

As far as the Agency’s total workload, which includes in-house pending ANDAs, and ANDAs awaiting response from industry; the number of pending ANDAs awaiting FDA action stands at 1460 and the number of ANDAs awaiting applicant action (which, by the way, dropped below 2000 for the first time this FY) now stands at 1995, representing 508 tentative approvals and 1487 outstanding complete letters (again the lowest for FY 2024) yet to answered.

There are many more details that are available and can be evaluated in this report by viewing the link provided in the first paragraph of this post.