June 15, 2010 / 8:08 AM / 9 years ago

Glaxo gets FDA okay for prostate combination drug

LONDON, June 15 (Reuters) - GlaxoSmithKline (GSK.L) has won U.S. approval for a fixed-dose combination prostate drug called called Jalyn, combining dutasteride and tamsulosin.

Both compounds are already marketed separately for the treatment of benign prostatic hyperplasia (BPH), or prostate enlargement, but Jalyn is the first treatment to combine them in one capsule.

The green light from the U.S. Food and Drug Administration had been expected following positive clinical trials. Glaxo said it expected to make the product available during the second half of 2010.

Dutasteride is marketed by Glaxo as Avodart. Tamsulosin is the active ingredient in Astellas Pharma’s (4503.T) Flomax, although the medicine is also available as a generic. (Reporting by Ben Hirschler, editing by Will Waterman)

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