Another month for FDA reviewers mostly on stay-at-home work due to the COVID-19 pandemic, and with the states beginning to open slowly, the Office of Generic Drugs (OGD) is chugging right along regarding its approval pace. OGD’s unofficial full approval actions for May of 63 is tied for second place among FY 2020 months thus far (last month there were 65 full approval actions). The month’s approval activity came in like a lion and went out like a lamb. The last 5 business days saw only 5 full approval actions and no tentative approvals, but the mid-month activity drove the total up.
OGD issued 9 tentative approval (TA) actions, well below the average for the first seven months of 14, and decidedly lower than the top month of April, where OGD issued 22 TAs. The total of approval actions for OGD in May appears to be 72, but, as always, some stragglers could come along prior to the release of the official totals around mid-May. The high for the year thus far was April with 87 total approval actions (66 full and 22 TAs).
The data presented is as of the morning of June 3, 2020 and is extracted for the FDA’s All Approvals list (here). Just search on May to examine the OGD actions on ANDAs. We will report more once the official metrics for the month are released by the Agency.
