Thursday, November 20, 2014

The biter bit?

Once again, Ranbaxy and its fraught relationship with the FDA are in the news, but for a very different reason this time - Ranbaxy is suing the US drug regulator. At issue are the approvals that the FDA granted to Ranbaxy in 2008 to manufacture generic versions of two drugs, Valcyte and Nexium. The FDA claims that these approvals were granted 'in error'; Ranbaxy claims that the FDA is acting in a manner 'arbitrary, capricious, and otherwise contrary to law' and has no authority to reverse a decision taken six years ago.