Over the Labor Day weekend, the FDA provided the latest full statistical report for the Office of Generic Drugs (here). The news continues to be good on the approvals front as the OGD issued sixty-nine full approval actions (one more than we captured in our unofficial peek (here) as the OGD snuck one by us). We hit the nail on the head with tentative approval actions at fifteen for the month, for a total of eighty-four approval actions in July.

To further break down the approval actions, of the sixty-nine full approvals, eighteen were for first time generics and ten (14.5%) were first cycle approvals. The OGD reported ten imminent approvals, which means that ten ANDAs were held beyond their goal dates to, hopefully, result in final approvals. Regarding the fifteen tentative actions, two (13.3%) were first cycle actions, and the OGD reported three imminent actions.

According to the official approval figures reported thus far this FY, it now appears that the FDA will hit 768 ANDA approvals in FY 2023, but I must tell you that the August unofficial approval actions, which I will report later this week (hopefully) after the OGD’s posts are complete, are looking very good!

The OGD refused-to-receive only one ANDA in July. In addition, the OGD issued 104 Complete Response Letters (the ten-month FY average is 125.5). In addition, the OGD acknowledged forty-five new ANDAs and approved 115 prior approval supplements in July.

There were 298 Information Requests (the ten-month average is 324.1) and 193 discipline review letters (just under the average of 202.6/month) sent by the OGD.

On the receipt side of the statistical chart, the OGD received thirty-six new ANDAs in July; while we anticipate a higher number new ANDA submissions in September prior to the implementation of the new FY 2024 GDUFA fees, we can only estimate 724 new ANDA for the full FY. This may likely be the first time since FY 2019 that approvals exceed receipts of original applications.

The OGD also received 234 amendments to applications and 874 supplements (of which 754 were CBE supplements and 120 were for prior approval supplements). Controlled Correspondences received popped back up to 325, well over the ten-month average of 307.2.

The number of ANDAs pending Agency action dipped slightly to 1,586 from last month’s 1,593, and those pending with the applicant fell to 2,039 from last month’s 2,060. This drop is likely attributed to the lower number of new ANDA receipts in July. These numbers total the OGD’s workload of pending ANDAs and work likely to come back into the OGD as applicants respond to Complete Response Letters. Take a look at the full report here to see some of the additional metrics reported by the OGD.