US FDA approves GlaxoSmithKline's Jalyn for symptomatic BPH; fast tracks Genzyme's MS drug alemtuzumab
The US Food and Drug Administration yesterday approved UK drug giant GlaxoSmithKline's Jalyn, a single-capsule combination of dutasteride (0.5mg) and tamsulosin (0.4mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. GSK expects to make the product available during the second half of 2010.
'This is the first time these therapies will be available together in a once-daily capsule,' said Anne Phillips, vice president, R&D medicine development leader at GSK, noting that 'Jalyn offers two mechanisms of action to provide symptom improvement and the ability shrink the prostate over a sustained time.'
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