Close
Blog & Resources Camargo Blog October 3rd, 2011

Don’t Launch Unapproved Products After 9/19/2011

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.



Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


Contact
Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
2505 Meridian Parkway
Suite 150
Durham NC, 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights