We can all sleep at night now, as OGD presented the official approval action numbers today (here) and the computer glitch that was reported earlier is in the rearview mirror (for now at least).
The good news is that OGD reported a total of 62 approval actions (20 more than appear on the FDA’s All Approvals page today – thus the glitch ate up 20 approval actions!). Official full approval actions for April were 45 of which 11 were first time generic approvals, along with 17 tentative approval actions.
Complete response letters bounced up a bit to 168, and OGD received a somewhat surprising number of new ANDAs at 64 which is the highest number thus far this FY (with the exception of December’s end of the calendar year flurry ([135]) and March (125) (which is the end of the FY in India).
