Overnight, the FDA posted its official approval numbers for May 2021 and the picture is not great. We reported in a previous blog post (here) unofficial totals of full-approval actions at forty-five and tentative‑approval actions at thirteen. We missed by one on each as the official numbers revealed forty‑six full‑approval actions and twelve tentative-approval actions for a total of just fifty-eight. We must look back to February of 2018 to find a monthly total lower than this (thirty-seven).
Of the forty-six approval actions, five were for first-time generic approvals. Complete response letters (CRL) issued also fell well below the monthly average of 158 and came in at 127, the lowest number of CRLs issued this FY in a given month. The OGD received forty-one new ANDAs, still on the low side of expectations, but you can’t blame the OGD for that! The official numbers can be viewed here. As the unofficial June mid-month blog report speculated (here), we could be in for a few “bad” months in a row!
