I had a call from a client who wondered if he could launch a new ‘DESI’ product. He had just read the FDA’s recent announcement that it would take immediate enforcement action on any unapproved drug introduced into the market after September 19, 2011. So, the question he asked was, is his “DESI” drug an unapproved drug?
As we have commented before in this blog, unapproved drugs are those that have not been approved by FDA either thru the NDA/ANDA process or thru the DESI process.
Since this client’s drug product was not approved via an NDA/ANDA (confirmed by the Orange Book and looking through discontinued products), we had to look at the DESI review.
The drug product had been reviewed under DESI almost 4 decades ago. The current product labeled indication and dose is not the same and the client told me that there is no market for the DESI-approved indication.
Hence, the client wanted to introduce a product that was not labeled per DESI and it would be unapproved.