Yesterday, OGD updated the final monthly statistics reported in the Activities Report of the Generic Drug program for FY 2016. While we had many of the activity numbers before, this final update provides additional information relevant to the program.
September 2016 saw the fewest number of Refuse-to-Receive (RTR) actions (9) with a FY 2016 yearly total of 246 with the most RTRs occurring in May 2016 (40). The 246 RTRs is the highest FY total since the beginning of GDUFA (2015 – 236, FY 2014 – 173, FY 2013 – 150).
September 2016 also saw the largest monthly total of CBE supplements at 678 for the year, with a total of 5666 for the year.
There was also a decrease of 1 in the number of ANDAs received in the report this month now standing at 852.
This is a follow-up to a previous report here. We will report on the first month of FY 2017, when those figures are released.