Correction on First Time Generic Approvals for FY 2016 – The Final Numbers Post

Yesterday, we posted an update on the first-time generic approvals from OGD for FY 2016.  At the end of the day (hours after our blog publication), the FDA updated their chart.  The number in the chart changed from 70 to 72 but then I noticed my error-the report was for the CALENDAR year not the Fiscal year.  I have revised the chart below to account for FY first-time approval since GDUFA is on a FY basis.  The numbers for the previous year are for appropriate FY

FY No. Of First Generic Approvals ANDAs Received during the FY
2013 108 968
2014 108 1473
2015 71 539
2016 83 852

The narrative stays pretty much the same as yesterday’s post but the numbers look a little better for FY 2016 than they did for FY 2015.  Sorry about the error, and I am glad that the FDA updated their chart so that I was able to catch the error quickly.