GSK Regulatory Update: Avodart
2009-11-23, Source: GlaxoSmithKline
![]() GlaxoSmithKline (GSK) announced today that in order to provide an update to the application, the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease. GSK expects to resubmit the file shortly. This action is not the result of new findings related to safety or efficacy.
Review of the EU filings will begin once the same update has been provided to the EU regulatory agencies.
Dutasteride is not approved or licensed in the US or Europe to treat or reduce the risk of prostate cancer. For more information about Avodart, please see the full prescribing information at www.gsk.com.
GlaxoSmithKline ? one of the world?s leading research-based pharmaceutical and healthcare companies ? is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
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