Today is September 13. 2023. That is not eye-catching news, but the fact that there has only been one ANDA reported as being approved is a bit troubling. We are hoping that this is a recurrence of a glitch in the FDA’s information systems and that ANDA approvals and tentative approvals are just not posting.
As of 3:25 p.m. ET, there was a lone ANDA approval listed on September 5th and, given the approval throughput we have seen in the past few months, either everyone has quit or there is a posting problem.
Hopefully someone at the FDA will read this post and check to see what is going on as I know that at least a few other ANDA approvals have actually occurred but are not posted. The last time this happened, it took about two to three months to fix. We will keep you updated if we hear anything from the OGD.
