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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to GlaxoSmithKline (GSK) for its supplemental new drug application (sNDA) for Avodart (dutasteride) which reduces the risk of prostate cancer in men at increased risk for the disease.
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GSK claims that Avodart and its generic counterpart, Dutasteride, are medications that are used to prevent the conversion of testosterone to dihydrotestosterone, or DHT, in a person’s body.
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.