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

 
• By Donna Young

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.

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.

The FDA told Teva the agency would not comment on the approvability of any application for any glatiramer acetate injection drug product, "because commenting on the approvability would be premature...

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