OGD published its official statistical report for April 2023 today (here) and we hit the nail on the head with our prediction of the number of full approval actions at 64 but we missed by one on the tentative approvals actions where we reported 11 (see previous post here), but there were actually 10 in the official numbers. Thus, OGD processed 74 approval actions during the month of April.
Of the 64 full approval actions, five (5) were for first time generic approvals and 11 (17.2%) were first cycle approvals. For the 10 tentative approval actions, two (2) (20%) were first cycle tentative approvals. Complete response letters (CRLs) dropped to a FY year low of 92, which is a bit surprising with the 7-month average metric now standing at 132. There were three (3) ANDAs that received refuse-to-receive letters, and two of the three were for priority applications.
OGD approved 120 prior approval supplements and issued 325 information requests (IRs) and 156 (second lowest for this FY) discipline review letters (DRLs). The number of ANDA awaiting Agency action (current workload) jumped back above the 1600 level to 1638 and the number of ANDA awaiting applicant action dropped to 2084, the lowest of FY 2023 to date. Remember, as applicants respond to more CRLs and submit more ANDAs, the number of ANDA awaiting Agency action increases. So, this is an up and down we will continue to see. However, not since the OGD began publishing these numbers have the number awaiting FDA action ever exceeded the number of ANDAs pending applicant action. Thus, there is lots of work the industry must complete before OGD sees these back in their active workload.
As far as receipts go, OGD received 44 ANDAs in April (7-month average of 64.8), 219 ANDA amendments, along with 712 CBE supplements and 127 PAS supplements. In addition, OGD received 278 controlled correspondences (CCs), broken down into 240 Level 1 and 38 Level 2 CCs.
Those are the highlights for the month and, for you real number nerds, a full set of the April statistics can be found here.