Lumiracoxib not approved by FDA

September 28, 2007 on 12:04 pm | In Prescribing Extra - Drugs | Print Print |

The Food and Drugs Administration has issued a ‘not approvable‘ letter for lumiracoxib (Prexige®) according to a press release from the manufacturer. PharmaTimes have also reported this story.

This rejection follows shortly after withdrawal of the drug in Australia, announcement of a full review of the drug in Canada and restrictions on use in Europe.

Action: Clinicians should be aware of the continued concerns about this drug. Patients on existing treatment should be changed to safer alternatives where possible.

Copyright ©2007 Prescribing Advice for GPs

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  1. [...] This article is based on blogs by Matt Robinson which can be accessed at http://www.prescriber.org.uk/2007/09/28/lumiracoxib-not-approved-by-fda/ [...]

    Pingback by NPCi blog » Blog Archive » Lumiracoxib ‘not approved’ by FDA — October 2, 2007 #

  2. Update: Health Canada has announced the immediate withdrawal of Market Authorization for Lumiracoxib.

    Comment by Matthew Robinson — October 5, 2007 #

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