Well, our unofficial projections got the full approval actions right (at 55) but we missed one tentative approval action that was posted late (we reported 16) (here) but the official total reported here actually tallied 17 for a total of 72 approval actions for April 2021.
11 of the 55 full approvals were for first-time generics which represented the second largest number of first-time approvals this FY behind the 16 of 72 reported in February. If the approvals continues at this rate, expect 768 full approvals by the end of FY 2021. It is going to be a race to see if approvals can outpace new ANDA submissions. Right now, it is neck and neck.
Complete response letters stayed relatively low at 149, the second lowest of the FY behind last month’s 140.
The good news is that there were 60 new ANDAs submitted in April with a full FY projection of 790 new ANDA submissions if the average holds for the rest of the year.
This is a strange year for sure, but what will the statistics tell us at year’s end? Stay tuned.
