Well, the numbers look good (as we predicted); however, we missed by a few in our crystal ball calculations. It is possible that at least 2-3 approvals for alternate strengths of previously approved products showed up in the charts, so we were a bit high on the projected full approval numbers (see here) and that is why we call them unofficial. Anyway, the official numbers that are most important to the industry for April are the approval actions which were 65 full approval (highest month this fiscal year, thus far) and 12 tentative approvals, for a total of 77 approval actions. Of the 65 approval actions, 10 were for first time generics and 19 (29%) were first cycle approvals. It has been a long time (if ever) since we have seen almost 1/3 of the full approval actions completed in the first review cycle! This is great news for industry, and especially if it persists. As far as the 12 tentative approvals, two (16.7%) were approved in the first cycle.

Complete response letters dipped to the lowest number this fiscal year at 112,the previous low was 120 in March 2024.The OGD issued only one refuse-to-receive action and acknowledged 53 new ANDAs.

Prior approval supplements approved shot up to 240, the highest number for the fiscal year to date. In addition, the OGD sent out 344 Information requests (171 on original ANDAs and 173 on supplements). The OGD also issued 159 discipline review letters which is slightly under the fiscal year monthly average of 166. The OGD is granting more reclassification of facility-based major CRL letters to minor, with a fiscal year high of 18 in April, while denying none of the requests received in April. Note that in the first seven months’ data, OGD has granted 64 of these requests and denied only two.

The OGD received 65 new ANDAs in April, the second highest since the end of year December’s number of 119. The rest of the monthly statistics look in line with what has been seen in prior months this fiscal year. In terms of the general ANDA workload, figures for original ANDAs, the number of ANDAs pending FDA action stands at 1476 while the number of ANDAs awaiting applicant action dipped to the lowest of the fiscal year at 2054, based on 497 tentative approval actions in their court, and 1557 completed response letters received for which a response has not yet been sent to the OGD.

The full set of the April 2024 statistical report can be found here .