In Brief: Teva's Copaxone
Executive Summary
Teva's Copaxone: Company receives a "refuse-to-file" letter from FDA for the NDA to treat multiple sclerosis, Teva discloses Aug. 21. Teva filed the Copaxone NDA on June 15. The agency cited an absence of information in the chemistry, manufacturing and controls section, according to Teva. The company has submitted additional data and expects to meet with FDA within the next 10 days to discuss the agency's refusal to file the NDA...
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