Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions.  Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received. 

The OGD officially issued 53 approval actions in December, along with 11 tentative approvals for a total of 64 approval actions for the month.  (By the way, I did that calculation in my head!  Go me!)  As far as approval actions go, those 53 were the second highest of this fiscal year, trailing October’s 57 full-approval actions.  December saw the fewest number of tentative-approval actions at 11, compared with the previous two months of 17 and 16, respectively. 

Of the 53 approval actions in December, four were for first-time generic approvals and twelve (22.6%) were for first-cycle approvals.  Let’s hope that percentage of first-cycle approvals holds and/or rises during the rest of this fiscal year.  The OGD also took nine imminent approval actions by extending the review clock to (hopefully) move the application to approval after the GDUFA goal date has passed.  As for the eleven tentative-approval actions, none of the actions were approved in the first cycle but the OGD did take imminent action on five ANDAs. 

Complete Response Letters totaled 131, the lowest number for a third straight month of decline.  The OGD issued only one refuse-to-receive letter in December, while it acknowledged 36 new ANDAs.  Information Requests hit 370 (about average) and Discipline Review Letters saw a third month decline in numbers to 158. 

The OGD approved 140 Prior Approval Supplements (PAS) and received 138 new supplements for about a zero-sum game with regard to PASs. 

The number of ANDAs pending Agency action increased to 1,475, the first increase in a while as the number has been steadily dropping over the year with only some minor fluctuation upward.  This is likely due to some good news that we will talk about a bit later in another blog post.  The number of ANDAs pending applicant action dropped slightly to 2,100 from 2,104 after five straight previous months of decline.  The 2,104 ANDAs awaiting firm action can be broken down into 494 tentatively approved applications and 1,606 CRLs with the firms awaiting response. 

Now for the good news!  The OGD received 119 ANDAs in December, with 23 of them being for complex products.  We have been somewhat concerned about the dwindling number of new ANDAs coming into the OGD but this end-of-year submission rush to file by industry looks promising. 

The number of supplements submitted in December dropped sharply from the mid-900s to 778 (640 for CBEs and 138 for PASs).  The number of Controlled Correspondences dropped to 213, which is the lowest number since January 2017 when 206 were submitted.  This, I believe, is an artifact as I know that we at Lachman are involved with a lot of Controlled Correspondences being submitted by firms.  The drop does, however, represent a fourth consecutive drop in the number submitted.  This is a trend that we will be watching closely. 

The number of post-CRL clarification-only teleconferences is on the rise in FY 2024, with the number of calls reported as three for October, seven for November, and eleven for December. 

With the first quarter behind us, the OGD reports its first quarter approval times as: 

  • Mean approval time: 39.84 
  • Median approval time: 26.07 
  • Mean TA approval time: 40.69 
  • Median TA approval time: 29.96 

Approval times are mostly higher than previous quarterly reports for FY 2023, with mean time for approval and tentative approval times up six months and five months, respectively, and median approval times up five months and tentative down about a month from the last quarter’s report.  Again, as we have previously noted, these metrics make it challenging for predicting and trending overall approval times as there are some very old applications still being approved as well as a number of ANDAs for which approval times have been delayed due to complex scientific or regulatory issues, like the nitrosamine problem.  With the constant jumping up and down for mean and median approval times from one quarter to the next, it is difficult to fully assess the implications for the program as a whole; however, I believe that if you keep an eye on the first-cycle approvals as well as the actual number of approvals and tentative approvals, these may be the key metrics that better define the OGD’s success. 

Now, for our first projections of approvals and receipts for the full FY 2024 based on the first quarter averages.  Assuming the same monthly trends for the full fiscal year, we estimate that the OGD will approve 644 ANDAs (138 fewer than last year’s 782) and receive 784 ANDAs (51 more than last year’s 733).  We will be watching these numbers closely and will report more on the estimates at the FY 2024 six-month mark.