FDA accepts Estorra NDA re-submission

Sepracor (SEPR) said FDA accepted for review its re-submission of an NDA for Estorra eszopiclone to treat insomnia. FDA classified the re-submission as Class 2, which allows the agency six months to complete its review. The resubmission was made in mid-June in response to a February FDA approvable letter that did not request additional clinical or preclinical trials for the single isomer of zopiclone (see BioCentury Extra, Wednesday June 16, 2004). Estorra is a non-benzodiazepine cyclopyrrolone GABA receptor modulator. ...