This month we will pat ourselves on the back as we captured the correct number of approval and tentative approval actions in our calculation of the unofficial numbers in our post here. We were more patient when looking at the February data from the daily approval page (which must be pieced together because it only provides a 14-day look back and the FDA All Approvals Report page here), and correctly predicted 52 full approval actions and 11 tentative approval actions! Thus, there were 63 ANDA approval actions taken for the month.

Of the February full approval actions, seven (7) were for first time generics and 13 (25%) were approved in the first cycle and OGD used the imminent action for five (5) ANDAs. Of the 11 tentative approval actions there were two (2)(18%) that were made in the first cycle review.

OGD issued a Fiscal Year 2024 high of 144 complete response letters in February, refused to receive only one (1) application, and acknowledged 75 new ANDAs during the month. In addition, OGD approved 141 prior approval supplements and issued 392 information requests (second highest this fiscal year) as well as 157 discipline review letters (the lowest number in any month this fiscal year).

February was a better month for receipts of new ANDAs as the Agency logged 64 new applications. Of the 64 new ANDAs, 16 were recorded as being for complex products. Also, OGD received 198 amendments during the month which was made up of 57 major amendments and 65 minor amendments.

The number of requests for reclassification of facility-based major CRL amendments tied the March high of 15. Firms seem to be becoming more comfortable with the use of this new GDUFA III tool.

OGD received over 1000 supplements in February (1014) for the second month in a row, 891were for changes being effected (CBE) supplements and 123 were for prior approval supplements (PAS). Even today in the Small Business Administration Seminar, OGD commented on the striking increase in the number of ANDA supplements that they have been receiving.

OGD received 321 Controlled Correspondences in February for the second month in a row that was over 300.

As far as the OGD and industry workload figures, the number of ANDA awaiting FDA action edged down a bit to 1427 while number of ANDAs awaiting applicant action jumped to 2109, an increase of 16 ANDAs from last month. The industry pending figure is broken out to 494 tentative approvals and 1615 complete responses that the Agency is waiting for industry response.

Looking at the 5-month average for approvals, it seems we are looking for a full Fiscal Year 2024 total of about 646 approvals, and for receipts the current projection is 713 new ANDAs. Both of these figures are below the Fiscal Year 2023 numbers of 782 and 733, respectively. Thus, our concern about both of these metrics heightens.

Please see the Generic Drugs Program Monthly and Quarterly Activities Report for February (here) which contains all the above statistics as well as some others that are available for public consumption.