Eisai receives not approvable letter for Aquavan

7/28/2008

NEW YORK The Food and Drug Administration has denied approval for a sedative for patients receiving minor medical procedures, according to published reports Friday.

The FDA sent Eisai a not-approvable letter for Aquavan, citing insufficient evidence showing that health-care providers without training in general anesthesia could use it safely.

Aquavan (fospropofol disodium injection) was developed by MGI Pharma, which Eisai bought for $3.9 billion in January.

X
This ad will auto-close in 10 seconds