OGD posted an update of its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) for March 2019.
As a mirror image of last month, OGD refused-to-receive (RTR) six (6) ANDAs, four (4) of which were standard review, and two (2) were for priority review applications. OGD sent 95 acknowledgement letters for new ANDAs in March, which is a monthly high for FY 2019 so far.
On the approvals side, of the 89 ANDAs fully approved in March, 11 (or 12%) were reported as being approved in the first cycle. For the 17 tentative approvals in March, two (2) (or 12%) were reported as being approved in the first cycle.
Information requests for both original and supplemental applications hit highs for FY 2019 at 257 and 139 respectively. 206 complete Response Letters for March were issued, over the average of 187 for the first 6 months of FY 2019. In another metric of interest, CBE supplements spiked to 841, well over the average for the first 6 months of 657 with the highest previous monthly total in 2019 of 679.
We will update you further as the approval, receipts, and complete response numbers come in for April.