Sandoz takes issue with FDA over biogenerics

I didn't think you could sue the FDA...

15/09/2005 - Sandoz, the generic drug unit of Swiss pharmaceutical group Novartis, has filed a law suit against the US Food and Drug Administration (FDA) alleging that the agency is dragging its feet in a review of a ‘biogeneric’ drug filed by the company.

Sandoz is calling for a swift ruling on its pending application to market its human growth hormone product Omnitrope, based on an abbreviated approval route that does not require the conduct of extensive clinical trials

link from inpharmatech.com