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FDA has approved it ... this article just came out...

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Date: 1/7/2002
Time: 5:29:59 PM
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Glaxo BPH Drug Approved by FDA November 26, 2001 ST. LOUIS (MD Consult) - GlaxoSmithKline's dutasteride, for the treatment of benign prostatic hyperplasia (BPH), has been approved by the US Food and Drug Administration (FDA)

GlaxoSmithKline officials said the agency had approved the drug, a 5-alpha reductase inhibitor.

GlaxoSmithKline said dutasteride is the first 5-alpha reductase enzyme inhibitor to inhibit both enzymes responsible for converting testosterone to dihydrotestosterone in the prostate, which is a key process in the development and progression of BPH. The drug has been tested on more than 4,300 BPH patients in clinical studies and has demonstrated long lasting symptom relief and positive impact on disease progression, GlaxoSmithKline said.

Other products currently on the market to treat BPH include Merck's Proscar (finasteride), Abbott Laboratories' Hytrin (terazosin), Pfizer's Cardura (doxazosin) and Sanofi-Synthelabo's Xatral (alfuzosin), all of which are alpha-1-adrenergic blockers.

The London-based firm filed for European marketing approval of dutasteride with Swedish regulatory authorities in early October.

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