UK regulatory agency clears prostate drug Flomax for OTC use; generic competition due next year in USA

14 December 2009

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has recently approved of the first over-the-counter (OTC) medicine to treat the symptoms of benign prostatic hyperplasia (BPH) in men, to be available through pharmacies without a prescription.

The drug in question, tamsulosin capsules, will be available to buy under the brand name Flomax Relief, for short-term use in men aged 45 to 75 following a consultation with a pharmacist. Tamsulosin was originated by Japan's Yamanouchi, now part of Astellas, and is marketed by licensee Boehringer Ingelheim of Germany

An estimated one-in-four men over the age of 40 suffer from BPH, the progressive enlargement of the prostate gland. Symptoms include urinary hesitancy, weak stream, and frequent urination, including at night.

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