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Vancocin Generics Launch As FDA Finds ViroPharma’s Label Fails “Significant New Use” Test

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA delivers an 87-page chef d'oeuvre that concludes the ViroPharma’s long-running battle to block ANDA approvals. In the citizen petition response, FDA rejects the firm’s scientific and legal arguments and concludes the antibiotic is not eligible for three years of Hatch-Waxman marketing exclusivity under a 2008 law. Although ViroPharma says it plans to sue FDA, the company may have bigger problems on its hands with an FTC investigation.

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