Biovail joined the increasing list of pharma companies that are downsizing or eliminating their 505(b)(2) development programs. As reported in the Wall Street Journal* Biovail CEO William Wells, in a conference call announcing a change in company focus, said “Focusing on the development of products that primarily provide convenience and compliance benefits is not a [...]
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Fospropofol turned down or approved by FDA Advisory Committee?
Published May 14th, 2008 in 505(b)(2) Issues and News Commentary. 0 CommentsMGI Pharma’s Aquavan(R) (fospropofol) is a phosphate prodrug of the anesthetic propofol. Propofol must be administered by an anesthesiologist because of its rapid onset.
The phosphate prodrug’s time to onset is delayed due to the conversion to the active moiety.
A slow onset of sedation would reduce the likelihood of sudden and unexpected general anesthesia. MGI hoped [...]