FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland

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Mar 02, 2010, 02:42 ET

Condition known as benign prostatic hyperplasia common in older men

SILVER SPRING, Md., March 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

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The most common symptoms of BPH include a weak stream during urination, urgency, leaking or dribbling, as well as more frequent urination, especially at night.

BPH is common among older men. According to the National Institutes of Health, it rarely causes symptoms before age 40, but more than half of men in their 60s and as many as 90 percent of men older than 70 have BPH symptoms.

"The approval of generic tamsulosin offers greater access to a widely used treatment for BPH," said Gary Buehler, director of the FDA's Office of Generic Drugs. "FDA is committed to making generic drugs available to patients and these drugs meet the same rigid standards as the brand name drugs."

The prescribing information and safety warnings for the generic version of tamsulosin are the same as those for Flomax Capsules. Generic tamsulosin capsules are manufactured by IMPAX Laboratories Inc. of Haywood, Calif. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

For more information

Consumer Information: Generic Drugs

http://www.fda.gov/Drugs/ResourcesForYou/ucm167906.htm

What BPH Means to Men – A Healthy Moments Podcast from the National Institutes of Health

http://www2.niddk.nih.gov/HealthEducation/HealthyMoments/04_06_2009.htm

Information on specific drug products, Drugs@FDA

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Media Inquiries: Sandy Walsh, 301-796-4669, [email protected]

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration