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)...
You may also be interested in...
Pfizer/Neurocrine File First Indiplon NDA With Eye On Q4 2005 Launch
The first of two NDA filings for Pfizer/Neurocrine's insomnia agent indiplon puts the drug on track for a launch in the fourth quarter of 2005
Aventis’ Estorra Rights Acquired By Private Equity Firm In $115 Mil. Deal
The Paul Royalty Fund II will purchase Aventis' U.S. rights for Estorra for $115 mil., the private equity firm announced Aug. 9
Sepracor Estorra Is “Approvable” For Insomnia; Launch Goal Is Mid-Year
Sepracor will resubmit its NDA for the insomnia agent Estorra in one to three months after receiving an "approvable" letter Feb. 27