Industry peers among FDA access-denial list

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.