June was a hot month for most of the East Coast, and it was a hot month for ANDA approval actions too (albeit but just a tad cooler than May’s numbers). OGD managed to issue 76 full approval actions and 17 tentative approval actions for a total of 93 approval actions in June. The 76 full approval actions are the second highest for any month this Fiscal Year behind the 85 full approvals reported in May.
There were a number of full approvals for additional strengths under the same previously approved ANDA numbers and there were also a few second tentative approval actions reported for the same ANDA numbers, so when the official June metrics for approvals are reported here (which will likely be sometime in early August), we are likely to see that the actual number of full and tentative approvals is somewhat lower than the above June numbers which are tabulated here.
Just to remind you, the apparent discrepancy created in these reports relates to actual “approval actions” that OGD takes on all ANDAs where the official numbers in the monthly report are based on the absolute number of ANDAs that are either fully approved or tentatively approved. This difference relates to the way OGD gets credited to the public for all of the approval actions it may need to take on each ANDA. This results in some ANDAs that have multiple “approval actions” (i.e. a second approval of a strength under the same ANDA, multiple tentative approvals based on split full and tentative approvals or amendments which cause a previously tentatively approved ANDA to cycle back to a pending application before being tentatively approved again). I know that it is confusing, but this is simply the way OGD tracks its individual actions.
Oh, and what about the World Cup? What great games there have been so far! With USA playing in the round of 16 later today, all I have to say is GO USA!
