RxTrials Institute Drug Pipeline Alert

The FDA has received MGI Pharma’s new drug application for Aquavan injection, an investigational drug being studied as a sedative-hypnotic agent in patients undergoing brief surgical or diagnostic procedures.
 
Data from Phase II and III trials in patients undergoing colonoscopy, a Phase III trial in patients undergoing bronchoscopy and an open-label study in patients undergoing a variety of minor surgical procedures form the foundation of the Aquavan (fospropofol disodium) application.

In total, data from 21 clinical studies with 1,611 subjects are included in the application.