On February 2, 2017 (here), we went out on a limb to suggest there may be an accurate method to track generic approvals throughout the month. We painstakingly tracked each daily report of the New and Generic Drug Approvals on the FDA web page for a month. We came up with 42 full approvals and 6 tentative approvals for January 2017. OGD just released its January official figures and now we can say – no, there is still not a good way to accurately track ANDA approval actions throughout the month. OGD figures reported on the Activities Report of the Generic Drug Program for January revealed that OGD actually approved 51 ANDAs and tentatively approved 14 ANDAs. Quite a discrepancy. Thus, I guess we will need to just wait for the Activity Report each month. Not sure how the Daily Approvals Report is prepared nor why it does not seem to provide complete daily figures, but this new report appears to be no better than the old FDA Monthly Approvals Report.
The 65 approvals actions (51 AP, 14 TAs) are the lowest for a single month so far this FY. The good news is that the number of new ANDA submissions was also the lowest of the FY at 57. With four months under our FY 2017 belt, projections for the full FY look like this – 660 ANDA approvals, 183 tentative approvals and a whopping 1443 new ANDA submissions (which we hope will decrease with each month). If the approval actions bear out, then we will be right on track with last year’s figures (651 and 184 respectively) and we wound up with 852 new ANDA submissions for FY 2016.
Complete Responses stayed at 144 (same as last month) with a monthly average of 147 so far in FY 2017.
OGD also updated its December statistics for certain items. Refuse-to-file actions sprang up to 24, bucking a three month (including one month from FY 2016) single digit trend. DMF Reviews popped up to 81 from around 50 and CBE supplements soared to 530 for December. 38 Prior Approval Supplements were received and the number of Controlled Correspondence dropped to 134, the lowest number since April 2016 when that same number of controls was received.
This is year 5 of GDUFA 1, and the questions remains – will the industry be satisfied with the progress made over the first iteration of a user fee program for generic products? Only time will tell.