Posted by reefer on October 3, 2004, at 14:51:05
In reply to Anyone heard anything about ESTORRA?, posted by jerrympls on October 3, 2004, at 0:51:20
From Sepractors site:
"In June 2004, Sepracor resubmitted its NDA for ESTORRA to the FDA. Resubmission of an NDA after receipt of an approvable letter is intended to answer all of the questions that need to be addressed prior to approval of the NDA. On July 15, 2004, the FDA accepted the resubmission of the New Drug Application (NDA) for ESTORRA™ brand eszopiclone for the treatment of insomnia as a complete response and has begun its review of the resubmission. The FDA has classified the resubmission as Class 2. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission was received. The Class 2 designation is consistent with Sepracor's previously announced expectations regarding the timeframe for the FDA review of the resubmission."
poster:reefer
thread:398436
URL: http://www.dr-bob.org/babble/20041002/msgs/398568.html