Sepracor resubmits Estorra NDA

SEPR resubmitted to FDA an NDA for Estorra eszopiclone to treat insomnia. In February, the company received an approvable letter from FDA that did not request additional clinical or preclinical trials. Under PDUFA, FDA now has 14 days to determine if the resubmitted NDA is complete and whether to classify the resubmission as Class 1 or Class 2. A Class 1 resubmission has a two-month review period, and a Class 2 submission has a six-month review period. ...