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February 21 2014

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1 to recommend against the expanded use of the drug. Avodart, Jalyn, and Proscar are approved to treat symptoms of an enlarged prostate. An FDA advisory panel voted 14-2 on Dec..The GlaxoSmithKline GSK drug Avodart dutasteride, already approved for treatment in men with enlarged prostate glands, has been rejected by the FDA for the additional indication of reducing the risk of prostate cancer. The new warnings, to be included in the Warnings and Precaution sections of the drugs labels, are based on the Food Drug Administrations FDA review of two large studies that indicated that men taking finasteride the active ingredient in Proscar and Propecia and dutasteride an active ingredient in Avodart and Jalyn were more likely to develop aggressive prostate tumors, even though their risk of less serious prostate cancer was reduced. Propecia, at a 1-mg dose, is approved to treat hair loss in men. Dutasteride capsule. .Jun 10, 2011 Parker Waichman LLP Proscar, Avodart, Jalyn and Propecia will all bear new warnings that they could increase the risk of high-grade prostate cancer, an aggressive form of the disease. Roughly 1 million men are currently estimated to be at risk for prostate cancer in the

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