GSK Regulatory Update - Avodart (dutasteride)
LONDON and PHILADELPHIA, March 29 GlaxoSmithKline (NYSE: GSK) announced today that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration (FDA).
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.
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
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 2009.
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