Firms Await Brazilian Regulator’s Decision On Allowing ‘Skinny Labels’ For Generics

The Brazilian medicines regulator, ANVISA, is considering whether to allow generic drug labeling to omit indications of the originator product that are still under patent. "Skinny labels" also figure in an ongoing court case involving Boehringer Ingelheim's Ofev (nintedanib).

Should Brazil allow generic medicine packs to omit indications still under patent? • Source: Shutterstock

Pharmaceutical companies and lawyers in Brazil are still awaiting the outcome of a consultation run by the drugs regulator ANVISA on plans to allow the use of “skinny labels” on generic medicines to avoid potential patent infringement.

The move would change the regulations so that the labeling of generic medicines could omit any indications of the originator...

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