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Hyderabad-based Natco Pharma said that USFDA has accepted the abbreviated new drug application (ANDA) for generic Copaxone filed by its marketing partner in the US, Mylan.
Copaxone is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). It had US sales of approximately $ 411.5 million for the 12 months ending June 30, 2014, according to IMS Health.
Natco in a statement said that Mylan expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval for the drug.
Copaxone is marketed by Teva Neuroscience Inc, which is a subsidiary of Teva, in the US.
