Well, as we predicted in an earlier post in December (here), it was postulated that the month would not be a great month for approval actions. However, OGD did issue 25 approval actions in the last nine business days of December and ended the month unofficially with 52 full approval actions and 7 tentative approval actions for a total of 59 approval actions for the month. We recognize that a few more might pop up when the official totals appear but that may be a month or two away as the November official totals have not yet appeared on the new Generic Drugs Program Monthly and Quarterly Activities Report for FY 2023. A previous post (here) explained that OGD was behind the eight ball in extracting the data for the new report based on new GDUFA III reporting requirements, so the delay is understandable. We will need to wait to see how long it takes OGD to get familiar enough with the process so that we will begin to see prior months official metrics within the 2-3 weeks that was the previous norm.
OGD has consistently issued approval actions for over 70 ANDAs a month in FY 2022, with 9 months breaking the 70 barrier and 1 of those months even hitting 94 for total approval actions. In October 2022, the first month of FY 2023, OGD issued 71 approval actions, and in November there were unofficially 69 approval actions. Looking back at previous years, December is a relatively prolific month for OGD ANDA approval actions, with most having well over 70 -80 approvals. We will have to see what the official numbers look like and hope that this was a one-off month. We will keep you posted!
