Ivax Generic Exclusivity On Glucophage XR Extends Beyond 180 Days
This article was originally published in The Pink Sheet Daily
Executive Summary
Court temporarily bars FDA from approving other metformin extended-release ANDAs after Ranbaxy challenges the agency’s decision to award a second exclusivity period. Ivax’ exclusivity was due to expire May 29; the company will gain at least an additional 30 days until a judge rules on the merits of Ranbaxy’s lawsuit.