Preview of June 2018 Approvals

As far as the available numbers for ANDA approvals and tentative approvals goes, for June, it appears we will have in the neighborhood of 67 full approvals and 6 tentative approvals for the month, more or less in line with what we have seen in the past few months.  These numbers were derived from the FDA All Approvals list (here) and the FDA Approved Drug Products list of daily approvals (here).  Based on these figures, which may be a bit higher when the official numbers are released, and using a straight-line projection, OGD is likely to approve about 749 ANDA in FY 2018.  That figure is only slightly below last year’s record of 763.

The good news is that July is off to a fast start with 11 approvals on July 2nd alone.  With just 3 months left in this FY, with a couple of good months, it is still possible for OGD to break the GDUFA approvals record.  More on this when the official counts are released in a few days.