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ViroPharma’s Failed Exclusivity Bid For Vancocin Could Spur Congress To Act

Executive Summary

FDA’s decision that vancomycin oral capsules do not qualify for Hatch-Waxman marketing protection under a 2008 law could become the focus of a legislative “fix” in pending user fee bills if lawmakers disagree with the agency’s conclusion that only approval of a “significant new use” for older antibiotics warrants exclusivity.

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FDA is using a recent court decision involving ViroPharma’s antibiotic Vancocin to argue for dismissal of a Mylan Pharmaceuticals Inc. lawsuit that seeks a determination on generic marketing exclusivity rights for Pfizer’s Lipitor.

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