January saw the highest number of full ANDA approval actions in FY 2026 thus far at 59 (one more than the 58 from November) along with 19 tentative-approval actions for a total of 78 approval actions for the month. This figure places January as the second highest in total approvals, also behind November, for the first four months of FY 2026.
The figures for total approval actions have been consistent thus far this fiscal year but they fall short of the numbers from FY 2025’s first four months, and they look more like the figures that were generated in the second half of FY 2025. Not sure whether this is attributable to the OGD staffing shortages, inspectional outcomes resulting in Complete Response Letters (CRLs) rather that approvals, lower numbers of first-cycle approvals, or just more complex ANDAs that are impacting quicker approvals. It will be interesting to see whether any clarity on these statistics is revealed at the AAM Annual Meeting in a few weeks. We’ll keep you posted!
