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505(b)(2) of Withdrawn Product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.