Flomax Approved In The USA
Boehringer Ingelheim's Flomax (tamsulosin hydrochloride) has beenapproved in the USA for the treatment of the signs and symptoms of benign prostatic hyperplasia. The recommended dose of the selective alpha1a antagonist is 0.4mg once-daily.
BI licenses the drug from Yamanouchi of Japan, which will manufacture it for the US market. The product was launched in Japan in 1993 under the trade name Harnal, and has also been approved in nine European countries. Annual sales are currently running at around $225 million.
The US approval was based on two multicenter studies, which showed that Flomax relieved the symptoms of BPH within one week of starting therapy, and maintained efficacy over the 13-week study period. Side effects included dizziness, rhinitis, infection and abnormal ejaculation.
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