FDA Questions Safety Of J&J, Bayer’s Xarelto

Law360, New York (September 6, 2011, 6:21 PM EDT) -- Voicing concerns about the effectiveness and safety of Johnson & Johnson and Bayer HealthCare LLC’s blood thinner Xarelto, U.S. Food and Drug Administration staff declined to recommend approval for the drug in a report released Tuesday.

The staff recommended a so-called complete response in briefing information about the rivaroxaban tablets prepared for the Cardiovascular and Renal Drugs Advisory Committee, which is poised to consider J&J's new drug application during its meeting on Thursday.

The company wants the FDA to approve the use of the drug to...
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