Blog & Resources Camargo Blog September 14th, 2007

505(b)(2) of Withdrawn Product

A source of 505(b)(2) opportunities comes from products that have been discontinued. One of the first things that must be done is to determine why it was discontinued – by law, the product must not have been discontinued for reasons of safety or efficacy. You can check to see if the FDA has made this determination. If FDA has not, then you must file a Citizen Petition. Camargo filed one last year and just got a (favorable!) response.

Now, how do you develop a drug when the RLD is not on the market? We’ll address that another day.

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.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights