Based on the FDA All Approval List (here, search for April), it appears that the Office of Generic Drugs had a banner month with 65 full approval actions and 22 tentative approval actions, for a total of 85 approval actions for the month. Of course, these are preliminary numbers, as OGD will not likely publish the official numbers until after the middle of May.
Both figures beat the FY 2020 monthly highs with previous highs for full approval actions of 63 in December 2019 and tentative approval actions of 17 in March 2020. It looks like work-at-home has been favorable to OGD approval actions thus far in 2020. However, we worry about the impact of FDA halting inspectional activity, and how that might play out for approval recommendations from the Office of Compliance if onsite inspections do not begin soon, and whether OGD will have to hold some approvals until later in the year awaiting facility clearance.
We will take a stab at Approval and receipt estimates for the full FY once OGD releases its official numbers.
