FDA Withholds Antibiotic Approval, Asks For More Tests
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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