Lipitor Generics: FDA Says Mylan Has No Standing To Sue (Until June 28?)
Executive SummaryFDA 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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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.