GlaxoSmithKline
GSK Regulatory Update - Avodart dutasteride
Published in Medical Letter on the CDC and FDA, April 18th, 2010
The re-submission provides an update to the initial application in 2009. The withdrawal of the initial application was not the result of new findings related to safety or efficacy. The update to the submission has not changed the interpretation of the data submitted.
The provision of this update to the European Regulatory authorities is also underway.
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