Lipitor Generics: FDA Says Mylan Has No Standing To Sue (Until June 28?)
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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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.
Lipitor Generics: Ranbaxy Still In The Driver's Seat As Court Dismisses Mylan Lawsuit Against U.S. FDA
Two unresolved factual matters stand in the way of Mylan Pharmaceuticals Inc.' s bid to sue U.S. FDA over generic marketing exclusivity for Pfizer's Lipitor, a U.S. federal judge ruled May 2
Lipitor Generics: Questions About Mylan's ANDA Weigh Heavily In Court's Dismissal Of Lawsuit Against FDA
Judge Boasberg says the court should not "prematurely intrude" on FDA resolution of two factual issues: the approvability of Mylan's atorvastatin ANDA and any generic marketing exclusivity determination involving Ranbaxy.