March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one). This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118. We believe this corresponds to the end of the fiscal year for India, which would account for the large number of submissions.
If we straight-line the figures for approvals and receipts at this 6-month point in the FY, we estimate 1064 approvals, 306 tentative approvals and 1024 new ANDA receipts.
FDA also updated its February 2019 stats. There were only 6 refuse-to-file, with 4 being for standard ANDA and 2 for priority review applications. The Agency reports 12 of 83 ANDA approvals were completed in the first cycle and 2 first cycle approvals out of the 19 ANDAs that were for tentatively approved applications in February.
All the other statistics that were updated for February are consistent with previous months.
The Agency’s review machine continues to work smoothly and places OGD in position to break approval records again.