FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland

FDA NEWS RELEASE
For Immediate Release: March 2, 2010
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
Condition known as benign prostatic hyperplasia common in older men

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.

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 Hayward, Calif. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.


For more information:

Consumer Information: Generic Drugs1
What BPH Means to Men – A Healthy Moments Podcast from the National Institutes of Health2
Information on specific drug products, Drugs@FDA3

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FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland