The Official Generic Drug Monthly Statistical report has issued (here) and is in a new format. As of this morning (August 5), the charts for the June data have not been updated; however, if you scroll down to the “Download Monthly and Quarterly Activities Dataset” button you can find the data metrics for June.
Let’s get right to the good news! OGD issued 77 full ANDA approvals in June along with 25 tentative approvals for a total of 102 approval actions for June! Of the 77 full approvals, 11 were approvals for first time generics; however, only 8 (10.4%) were for first cycle approvals. This drop in first cycle approval rate is a bit troubling, as OGD had hit a 26% first cycle approvals in April and we thought it might stay in that range. Eleven of the approvals came through from the imminent approval scheme where the goal date has passed but finalization of some minor issues allowed the application to gain approval during the current review cycle. Through June, OGD has fully approved 541 ANDAs, and, if the rate of approvals continues for the rest of the FY, OGD will likely approve about 721 ANDA applications for the full FY.
As far as the 25 tentative approvals, 10 (40%) were approved in the first cycle! Now that really is an impressive number!
OGD issued 90 complete response letters in June and did not issue any refuse-to-receive letters for the third month in a row. OGD also acknowledged 55 ANDAs in June. In addition, OGD approved 122 prior approval supplements, issued 464 information requests (273 for original ANDAs and 191 for supplements), along with 205 discipline review letters (the highest number for any month thus far this FY).
As a measure of the in-house workload, OGD reports that the number of ANDAs awaiting OGD action dipped from the May number of 1316 to 1254 in June. The number of applications that the Agency is awaiting a response from sponsors ticked up slightly to 1784, represented by 574 tentative approval letters and 1210 outstanding complete response letters.
On the receipt side of the house, OGD received only 41 ANDA in June. If the current trend continues, it looks like OGD total ANDA receipts will hit only about 609 for the full FY, just 6 more than OGD received in FY 2025. This continues to be a concern for the program
OGD only received 136 amendments, comprised of 50 major, 31 minor and 55 unsolicited amendments. OGD cracked the 1000 mark for supplementals received for only the second time this FY with the receipt of 1038 supplements broken down by 871 CBEs and 167 prior approval supplements.
While we expected to see the OGD reporting of mean and median approval times for the third quarter along with the June Data set, the quarterly report has not yet been updated for these two metrics. Once OGD publishes this information, we will be providing an update to this post.
