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FDA denies Teva's 7th petition to stop generic Copaxone

This article was originally published in Scrip

Executive Summary

The FDA, for the seventh time, has denied a citizen petition from Israeli drug maker Teva requesting US regulators not approve an abbreviated new drug application (ANDA) that references the company's multiple sclerosis (MS) drug Copaxone (glatiramer acetate injection) unless certain conditions are satisfied.

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