ANDA approval actions totaled 66 this month, with 51 full approvals (APs) (a little below the monthly average of 55.7 in year 4 of GDUFA so far) and 15 tentative approvals (TA). Receipts picked up to 79 for the month for the third highest month of this fiscal year (FY) (behind 180 in December and 114 in March). So far this FY, there are 502 full ANDA approvals, 144 TAs, and 665 new ANDA receipts.
With 9 months of data behind us for FY 2016, if we straight line average for the two metrics of most interest to industry, expect about 669 full approvals and 887 receipts for this FY.
The number of Complete Response Letters (CRLs) that were issued in June was 166. This represent the second highest output for a month, behind 190 in April. Monthly averages would show a FY total of about 1595 CRLs, with is up significantly (26%) over the FY 2015 complete year total of 1180. Refuse-to-File actions look like they will edge out last FY’s total of 236 by about 21 if FY 2016 monthly averages continue for the rest of the year.
As we come to the close of the third quarter of this FY, OGD appears to be on track to exceed its numbers for approvals and CRLs. Only industry can tell use what’s in store for approvals for the next quarter. Keep tuned!