Well, after a somewhat underwhelming start to FY 2024 (which began in October 2023), as reported here, it looks like things are picking up on the approval front for ANDAs. With approval postings through January 17th available today, the OGD has issued thirty-two full-approval actions and ten tentative-approval actions. This should bode well for a better January outlook.
While I am still somewhat concerned about the lower number of new ANDAs being submitted to the Agency and the potential impact on the long-term health of the OGD’s workload, I will hold my worry under control as long as our march through FY 2024 does not further downturn. The good news is, if the workload stays lower, the approval times should improve. But the balance (or the yin and yang) between the two metrics, approvals and new ANDA receipts, is still important.
