In an earlier post (here), we projected the June approval number to be 52 full approval actions and 19 tentative approval actions. This morning the FDA published its official approval actions as well as other metrics (here) and our projections were spot on. The total of 71 approval actions (52 + 19) were exactly what OGD posted. Of the 52 full approval actions OGD reports that 6 of these actions were for first time generic approvals. OGD also reported 58 new ANDAs receive in June.
These results allow us to do some projections for the full fiscal year. With data from 3 full quarters, and if the trends continue at the current pace, OGD should fully approve 721 ANDAs and should receive 856 new ANDAs for the full FY. This would represent an increase of 42 approvals over the 679 seen in FY 2021 and about 47 more new ANDAs over the 809 received last FY.
The other official metrics reported overnight was the issuance of 159 complete response letters slightly higher than the FY 2022 nine-month average of 151.
OGD will report the remainder of the official statistics for the month in about 203 weeks and we will be on top of that for you.
