Mylan suit pushes FDA to decide immediately on Ranbaxy ANDA for generic Lipitor
This article was originally published in Scrip
Executive Summary
The US FDA has yet to clear any of the generic competitors as equivalent to the blockbuster Pfizer statin Lipitor (atorvastatin). But now Mylan has sued the agency in federal court in an effort to have a generic come to the US five months earlier than expected. It seeks a ruling from the court that the agency must "immediately decide" and "make public" its position on the status of Ranbaxy's ANDA.