We were close on our unofficial approval numbers for December reported here for approval actions and tentative approval actions (63 and 20 respectively) as the official numbers reported today by OGD are 63 and 22, respectively. Looks like 2 TAs snuck onto the approvals listing late in the game.
Of the 63 approval actions in December, 7 were reported as first generic approvals. In addition, OGD reported issuing 154 complete response letters for the month, the lowest of the months in the first quarter of FY 2021. On the more positive side of the ledger, OGD received a whopping 124 new ANDA submissions in December, beating the abysmal number of submissions in the first to month (total of 60).
So, here come the first estimates for the full 2021 FY – at the current rate, we expect approval actions of about 784 and number of ANDAs received to be about 736. That would show an improvement in the total number of approval actions over the 737 last FY which was the lowest since GDUFA began and a dip in submissions over the 2020 FY’s 865.
The updated statistics for November of interest show 6 refuse-to-receive actions issued for 5 standard ANDAs and one priority submission. Of the 55 full approval actions in November, 7 or just under 13% were first-cycle approvals. Also, of the 21 tentative approval actions, 4 or 19% were first-cycle approvals.
ANDA amendments popped back just over the 200 mark at 204. Changes being effected supplements continue their march upward, with 961 being submitted in November and controlled correspondences continued over 300 at 305 for the month. The remainder of the metrics reported appear to be average in nature but you can see them all here.
We will update the December stats sometime towards the end of January or the first week or two in March when FDA releases those updates.
