Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics. We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 (we reported 83) and tentative approval actions were 10, for a total of 94 approval actions, which is the most since May 2019 when there were 95 total approval actions.
Of the 84 full approval actions, 30 were for first time generic approvals, with two products (pemetrexed [13] and bortezemib [8])) accounting for 21 of the first time generic approvals. FDA issued 125 complete response letters (CRLs) in May, the second lowest of the FY behind December 2021 with 108 CRLs issued.
There were a surprising number of new ANDAs submitted in May (74), the highest number of submissions since May 2014 when 134 were submitted (that was the crazy year of submissions when the full year saw 1473 new ANDAs submitted).
As far as April updates of interest, OGD refused-to-receive 5 ANDAs and acknowledged 70 new ANDAs. Of the 45 ANDAs approved in April, eight or 18% were first cycle approvals and, of the 17 tentative approval actions, 3 or 17% were approved in the first review cycle.
Information request declined to 324 (average of 7 months 373/month) while discipline review letters were the lowest of the FY at 141 (average of 7 months 186/month). CBE and PAS supplements were towards the middle of the pack, while both controlled correspondences (349) and post-CRL meeting requests (7) hit new highs for FY 2022.
Looking at the average number of approvals per month now, OGD is likely to fully approve 693 ANDAs in FY 2022 and should receive about 876 new ANDAs. We can see the gap widening between approvals and receipts and will likely place a bit more strain on the program unless first cycle approvals increase.
You can see the full report of OGD statistics for FY 2022 here.
