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news.GlaxoSmithKline (GSK) has re-filed 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 FDA.
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Reportedly, GSK had filed a supplemental new drug application (sNDA) for Avodart (dutasteride) with the FDA on 1 October, 2009.
GSK said that 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.
Additionally, 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.
Avodart alone and in combination with the alpha blocker tamsulosin treats urinary symptoms of benign prostatic hyperplasia (BPH). Avodart alone also reduces the risk of acute urinary retention (AUR) and prostate surgery. AUR is a condition, possibly requiring surgery, where the prostate is so enlarged that it completely blocks urine coming from the bladder.