Jalyn approved for benign prostatic hyperplasia (BPH)

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.

For more information call (888) 825-5239 or visit www.gsk.com.