With the caveat that the counts of monthly approvals are not official until OGD publishes those results in an updated version of the Activities Report of the Generic Drug Program, it appears that OGD will break a record of monthly approvals for June 2017. From data gathered from the daily approval report, I find at least 84 full ANDA approvals, the highest full approval total since the inception of GDUFA. This would be a third month in a row where approval actions are up over the averages we have seen and bodes well for the trend we hoped we would see. We also found 8 tentative approvals in June.
We will report on the official totals once the above-referenced report is updated. Have the flood doors opened for approvals? Will receipts still outpace approvals? Stay tuned.