FDA extends Sepracor Estorra action date
Executive Summary
Sepracor expects April launch for sleep disorder drug Estorra (eszopiclone) following FDA decision to extend drug's user fee action date three months to Feb. 29, 2004, Sepracor tells Nov. 13 call. Sepracor Exec VP-R&D Mark Corrigan says the extension was "purely an administrative action" and not related to the safety or efficacy of the drug...