PharmaRoth Looks Abroad With Type 2 Diabetes Product After NDI Notification Decision
This article was originally published in The Tan Sheet
Executive Summary
FDA decides Sucanon is an investigational new drug, not a dietary ingredient, in response to PharmaRoth Labs’ NDI notification. The firm expected to sell Sucanon as a consumer health supplement via infomercials with no claims, but faces substantially higher costs on the IND pathway to market.