MGI Pharma MOGN New patents, anti cancer Message Board

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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer

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To: rkrw who wrote (1780)	8/29/2007 4:19:50 PM
From: Ward Knutson	of 1826

<<Why would propofol require an anesthesiologist and aquavan wouldn't?>> Propofol was developed as an induction or maintenance agent for general anesthesia, or monitored anesthesia care sedation - the label reflects this. Aquavan has not been developed or studied in these settings. The Aquavan trials are in the minimal to moderate (conscious sedation) setting. If propofol was studied by a manufacturer (Astra-Zeneca) for this same setting, it would likely have a recommended dosage schedule that would result in a different label - the type of label being pursued by MGI for Aquavan. The FDA is not going to "re-label" propofol based upon petitions, they would gladly re-label it if someone ran adequate, well controlled phase 3 trials demonstrating efficacy and safety in this setting. No one has, and no one will - generic manufacturers do not spend $25-50 million for such programs. The largest competitor in the Aquavan market is not propofol, it is midazolam. That is the agent that FDA wanted in the colonoscopy as a safety comparison, not propofol.

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