March approvals appear to be moving in the right direction as firms, apparently, are catching up with elemental impurity issues and their amendments are working their way through the review and approval process. Unofficial March ANDA approval numbers taken from the Recent New and Generic Drug Approvals list (here) show 50 full approvals and 10 tentative approvals. Our usual caveat that the official numbers may have a few more when posted in about a week or so applies yet again.
These current numbers show an 100% improvement over the 25 approvals in January 2018, and are substantially higher than the 32 approvals in February.
We will report on the official numbers when they come out, which will also include ANDA receipts and Complete Response Letters. Hopefully, in the next couple of months, we will be back to seeing more approvals that approach what we have come to know as the norm.
