Mylan Sues FDA Alleging Inaction And Failure To Share Clarity On Ranbaxy's Atorvastatin Filings
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Two months after settling a patent litigation with Pfizer Inc. for cholesterol-reducing agent Lipitor (atorvastatin), generic drugs major Mylan Pharmaceuticals Inc. has charged that U.S. FDA's failure to decide and disclose critical information related to Ranbaxy Laboratories' Ltd. abbreviated new drug application for atorvastatin is "unlawful, arbitrary and capricious.