Pfizer has withdrawn U.S. and European marketing applications for dalbavancin--a drug for complicated skin and skin structure infections in adults--following feedback from regulatory agencies. The company now plans on conducting another Phase III trial of the drug on infections caused by Gram-positive bacteria, including MRSA. Pfizer will also start a pediatric program for the drug.
"After careful consideration of feedback and ongoing dialogue with regulatory authorities, Pfizer has decided to study dalbavancin further in patients with complicated skin and skin structure infections," said Dr. Mark Kunkel, Pfizer's Global Medical Therapeutic Area Leader for Anti-infectives and HIV. Pfizer acquired dalbavancin when it bought out Vicuron Pharmaceuticals in 2005.
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