FDA Panel To Discuss New Drug Label Warnings

Law360, New York (March 24, 2008, 12:00 AM EDT) -- A panel of U.S. Food and Drug Administration outside advisers is set to discuss whether Baxter International Inc. should follow the FDA's recommendation to revise the labeling for its inhaled anesthetic drug Suprane.

The Pediatric Advisory Committee, as the panel is known, will also discuss the FDA’s request for Salix Pharmaceuticals Ltd. to add a new warning to its Colazal labeling when it meets Tuesday in Gaithersburg, Md., the FDA has announced.

Suprane is indicated for induction and/or maintenance of anesthesia for inpatient and outpatient surgery...
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