The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here). So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY). OGD did say there would be good and bad months for approvals and the July number of 46 ANDA approvals is the second lowest this fiscal year (the lowest was 43 in January 2016). In addition, it was also the second lowest month for Tentative Approvals at 10 this month (previous lowest month was 6 in November 2015).
Receipts for the month stood at 69 and the total for the FY through 10 months stands at 733 with a straight line projection of 881 if the submission rate continues the same over the next two months. OGD can expect to approval 656 ANDAs during FY 2016 with the same approval rate. The gap between receipts and approvals is narrowing but still exists. Hopefully, GDUFA year 5 will see even a bigger uptick in approvals as the review goal tightens to 90% in 10 months.
Complete Response Letters continue at the about the same pace as last few months which registered the 4 highest number of CRLs this FY (190, 151, 166, and 170, respectively, over the last 4 months).
All-in-all, OGD has improved its output on approvals, tentative approvals and CRLs. But industry keeps the submission rate higher than the number of approvals. There certainly needs to be more concentration on first cycle approvals (data has only been made available for the first two cohort years of FY 2014) and that will take work on the part of both the FDA and industry. Industry must improve the quality of its applications and the FDA must improve the speed at which it can review applications. October 1, 2016 starts the 5th year of GDUFA with the most stringent review timelines of the program to date. This may be where the rubber meets the road.
