U.S. FDA Slams Ranbaxy’s Claims In Nexium, Valcyte Lawsuit
This article was originally published in PharmAsia News
Executive Summary
The U.S. drug regulatory agency highlighted Ranbaxy’s faulty manufacturing practices, strongly retaliating to its claims in a lawsuit challenging the recent decision to rescind tentative approvals for generic versions of Nexium and Valcyte. Among others, the FDA brought up a few strong points like how it had backed arguments in the past that led to Ranbaxy gaining exclusivity approvals on two drugs.