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)...