Nov 13 · 11:34:00 AM · Source: Company News Release

Cadence Pharmaceuticals, said Friday the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.
The company said it remains confident in its NDA submission and will continue to work closely with the FDA toward the potential approval of intravenous acetaminophen, noting it is now planning for a launch early in the second quarter of 2010.

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by Larry Etter