Sepracor Estorra Is “Approvable” For Insomnia; Launch Goal Is Mid-Year
Executive Summary
Sepracor will resubmit its NDA for the insomnia agent Estorra in one to three months after receiving an "approvable" letter Feb. 27
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Sepracor Estorra timeline
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)...
Sepracor Estorra timeline
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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