Drug Information Update- FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland

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Title: Drug Information Update- FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration has 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.

For more information, please visit Tamsulosin


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