Industry peers among FDA access-denial list

Executive Summary

Generics firms including Teva, Mylan, Sun’s Ranbaxy and Hikma’s Roxane are among almost 40 sponsors of reference drugs identified by the US Food and Drug Administration (FDA) on a list of “access inquiries” relating to difficulties experienced by generics firms in obtaining samples for development. Other companies named as sponsors of a reference listed drug (RLD) for which the FDA has received an access inquiry include originators such as AstraZeneca, Bayer, Boehringer Ingelheim, GlaxoSmithKline and Novartis.