FDA Seeks Panel Expert Review Of Antibiotic

Law360, New York (November 17, 2008, 12:00 AM EST) -- An experimental antibiotic developed by drugmaker Theravance Inc. to treat complicated skin infections may cause possible kidney damage, birth defects and death, according to the U.S. Food and Drug Administration's review of the drug.

FDA reviewers prepared the report for an outside advisory panel of antibiotic experts scheduled to meet Wednesday when the agency will ask the panel if the data for the once-a-day telavancin indicate that the injectable drug is safe and effective for treating bacterial skin infections despite findings that the antibiotic may be...
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