Cadence Pharmaceuticals Inc. (CADX) announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act or PDUFA goal date for its Priority Review of the New Drug Application or NDA for intravenous or IV acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.
The FDA designated one of Cadence's submissions to the NDA, which contained additional clinical pharmacology data requested by the agency during the review process, as a major amendment.
The company said that the FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide time to complete the review. The FDA is not requesting any other information at this time.
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