To date, according to the FDA All Approvals report (here), so far this month there have been 54 recorded full approvals and 11 tentative approvals. Of course, we have today, July 31, not yet reported and there will be a few posting of approvals over the last 2-3 work days, but, unless there is a real surge, we will be back to the 60’s for total approval actions for the month.
Realistically (and Dr. Uhl even said this), there will be good months and bad months; well, this is not a bad month, but it appears to be an average month. Remember, there are a lot of pieces that must come together to issue an approval action, and those pieces come from several different Offices within the Center. You have the Quality review from the Office of Product Quality, the bioequivalence labeling and patent and exclusivity reviews from the Office of Generic Drugs, the compliance review for the Office of Compliance and any consults from the various review divisions as well as the resolution of any legal issues, petitions etc. from the Office of Chief Counsel and the Office of Regulatory Policy. If one of those reviews is not ready, the ANDA cannot be approved.
It is like putting a jigsaw puzzle together and sometimes the last piece falls between the cushions of the couch and it take a while to find it. OGD did have a couple of big days – July 7th with 5 full and 3 tentative approvals, and the big daddy of the month so far, July 21 with 11 full and 1 tentative approvals.
We will still have to wait for the official totals for the month but don’t expect to see OGD near a record this month, yet they are still doing a good job getting in the upper 60’s for approval actions. Also, one must remember that July has not been a particularly strong month for approvals possibly because it is summer and lots of staff take vacation this month.
