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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Lumiracoxib not approved by FDA

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.

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3 Comments to “Lumiracoxib not approved by FDA”

  1. I dont understand why FDA not approved this fantastic drug like this, because this is simply boon for the patients who have gastric ulceration. It has some Cardiovascula side effects but its true for all NSAIDs.

    Comment by Ziaur Rahman — May 19, 2009 #

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

    Comment by Matthew Robinson — October 5, 2007 #

  3. [...] 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 #

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