Indevus reaches agreement with FDA on resubmission for Nebido
This article was originally published in Scrip
Executive Summary
Indevus Pharmaceuticals has reached an agreement with the US FDAregarding a path forward for its long-acting testosterone depot, Nebido (testosterone undecanoate). The company says it will be able to submit newly gathered information on the incidence of oil-based reactions from existing clinical trials as opposed to conducting further trials in order to resubmit its NDA.