The FDA has approved GlaxoSmithKline’s Jalyn, a fixed dose combination of dutasteride and tamsulosin, for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. This approval was based on two-year results from the international, multicenter, randomized, double-blind and parallel-group CombAT (Combination of Avodart and Tamsulosin) study conducted in 4,844 men with BPH. The study compared changes in urinary symptoms seen with dutasteride co-administered with tamsulosin as opposed to either medicine alone.
Jalyn is expected to be made available in a dutasteride 0.5mg/tamsulosin 0.4mg dosage strength capsule during the second half of 2010.
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