A month and half after the close of the January books, we now get a look at the output and incoming workload of the Office of Generic Drugs for January 2024, the fourth month of Fiscal Year (FY) 2024. I will provide some of the highlights of the Generic Drugs Program Monthly Report, but you can see the entire report (here).

From my perspective, the two most important pieces of information in the report deal with ANDA approvals and new ANDA receipts, as those two metrics represent the bread and butter of the generic industry and OGD. OGD approved 56 new ANDAs along with the issuance of 17 tentatively approved (TA) ANDAs in January 2024. (Note – in early February we unofficially reported (here) that, in January 2024, there were 55 full approvals and 19 tentative approvals. Looking back, we note that one (1) of the ANDA approvals was listed after our unofficial report and two (2) of the TAs reported were either as duplicates or were for different strengths within the same ANDA. Of the 56 new ANDAs approved in January, six (6) were for first time approvals and nine (9) (16%) were for first cycle approvals. Of the 17 TAs issued, none of the actions were taken in the first ANDA review cycle. This is the third month in a row that no TAs were approved in the first cycle. It may be that TAs are more difficult to approve in the first cycle due to labeling changes and other various patent and exclusivity changes that occur during review (among other factors), but we also have seen over the years, that 3-4 months with no first cycle TAs are common.

The number of new ANDA receipts dropped from a robust 119 in December to a concerning 37 (the second lowest since October 2023 when 26 new ANDAs were received by the Agency). Through the first four months of FY 2024, OGD received 233 new ANDAs, which, at that rate, would translate to 699 ANDAs for the full fiscal year, the lowest since FY 2015, when only 539 new ANDAs were received (that was an unusual year, as a change in OGD Refuse-to-Receive policy went into effect, causing a very low number of ANDA accepted for receipt; there were 236 ANDAs that received Refuse-to-Receive letters that year). The projected number of new ANDA receipts (699) continues to trouble me as the number of ANDAs submitted in the early days of GDUFA were in the 1000s and now it seems like in the last three years, those number keep dropping- from 857 to 733 and (if my projections are accurate) 699 this fiscal year.

OGD issued three (3) Refuse-to-Receive letters, 136 Complete Response letters, 318 Information Requests, and 160 Discipline Review letters, consistent with what we have seen in previous months this fiscal year. OGD did acknowledge 84 new ANDAs because of the large end-of-year December new ANDA submissions.

As far as other receipts of note, OGD received 15 requests for reclassification of a facility-based major CRL amendment. This is the highest number of requests received for this newly implemented GDUFA III program. The numbers have risen steadily since the program went into effect in October 2023 with 4, 6, 12, and 15 requests being submitted (respectively) in each of the first four months.

OGD got slammed with 1000 supplements (948 CBEs and 152 PASs), the most since May of 2023 when OGD received 1012 supplements. It is also interesting to note that January was the first month this fiscal year that the number of controlled correspondences popped back over 300 at 329.

Pending ANDAs awaiting FDA action dropped in January 2024 to 1451 from 1475 in December 2023, while the ANDAs awaiting applicant action dropped slightly from December’s total of 2100 to 2093 in January.

Not a lot of surprises in January, but there is also some increased concern regarding the number of ANDAs being submitted. As noted earlier, you can see the full statistical report at the link cited above.