FDA Withholds Antibiotic Approval, Asks For More Tests

Law360 (October 23, 2006, 12:00 AM EDT) -- The U.S. Food and Drug Administration has refused to allow Replidyne Inc. and Forest Laboratories Inc. to market an oral antibiotic and has requested further testing, the companies said Monday.

The companies said that the FDA issued a non-approvable letter for the new drug application for oral antibiotic faropenem medoxomil.

“In its letter the FDA did not raise any safety concerns or chemistry, manufacturing or controls issues related to the product,” the companies said. “Replidyne and Forest intend to discuss the clinical plans with the FDA...
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