GSK Regulatory Update: Avodart
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
Issued: Monday 23 November, London UK
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
GlaxoSmithKline Enquiries: |
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UK Media enquiries: |
Philip Thomson |
(020) 8047 5502 |
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Claire Brough |
(020) 8047 5502 |
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Stephen Rea |
(020) 8047 5502 |
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Alexandra Harrison |
(020) 8047 5502 |
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Gwenan White |
(020) 8047 5502 |
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US Media enquiries: |
Mary Anne Rhyne |
(919) 483 2839 |
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Kevin Colgan |
(919) 483 2839 |
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Sarah Alspach |
(919) 483 2839 |
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European Analyst/Investor enquiries: |
David Mawdsley |
(020) 8047 5564 |
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Sally Ferguson |
(020) 8047 5543 |
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Gary Davies |
(020) 8047 5503 |
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US Analyst/ Investor enquiries: |
Tom Curry |
(215) 751 5419 |
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Jen Hill Baxter |
(215) 751 7002 |
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.
