Thursday, September 15, 2005

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

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