GSK Receives FDA Complete Response Letter for Avodart for Prostate Cancer Risk Reduction Supplemental Indication
LONDON and PHILADELPHIA, Jan. 26, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).
A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form.
This notification refers solely to the supplemental file specific to a prostate cancer risk reduction indication and not the existing FDA-approved uses. Avodart is approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery In combination with the alpha-blocker tamsulosin, Avodart is also approved for the treatment of symptomatic BPH in men with an enlarged prostate.
For more information about dutasteride, please see the full prescribing information at 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 2009.