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Generic Drug for Enlarged Prostate Approved

FDA OKs Generic Version of Flomax for Treatment of BPH

By Kathleen Doheny
WebMD Health News

Reviewed By Louise Chang, MD

March 2, 2010 -- The first generic version of Flomax, a medication to treat the signs and symptoms of an enlarged prostate gland, has won the approval of the FDA.

The generic version of Flomax, known as tamsulosin, will be made by IMPAX Laboratories of Haywood, Calif. Under FDA regulations, the generic versions must meet the same standards as the brand name drug, says Gary Buehler, director of the FDA Office of Generic Drugs, in a news release.

Enlargement of the prostate gland, a condition known as benign prostatic hyperplasia (BPH), is common among men as they age. More than half of men 60 and older and more than 90% of those 70 and older have BPH symptoms, including a weak urine stream, leaking or dribbling, frequent need to urinate at night, and urinary urgency.

The condition is not cancerous.

The prostate is a walnut-shaped gland located just below the bladder. It produces fluid for semen. But when it grows too big, the prostate puts pressure on the urine-carrying canal or urethra, which passes through the prostate, and this can result in the urinary symptoms.

According to information on the Flomax web site, the drug works by relaxing muscles in the prostate and in the neck of the bladder. Somewhat like releasing a pinched straw, it is then easier for urine to pass out of the body.

Those taking the drug are cautioned to avoid hazardous tasks or driving until they know how the drug affects them. Commonly reported side effects include a runny nose, dizziness, and a decrease in semen, although the drug is not linked with a decrease in sex drive nor impotence.

SOURCES: News release, FDA.

Flomax web site.

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