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Sepracor Estorra timeline

Executive Summary

Sepracor is anticipating a year-end 2004 approval for Estorra (eszopiclone) after resubmitting an NDA for the insomnia agent in response to an FDA "approvable" letter. Sepracor now expects to receive a six-month review from the agency; the company had been optimistic that FDA would review the resubmission in two months (1"The Pink Sheet" March 8, 2004, p. 34)...

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