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news.GlaxoSmithKline (GSK) has sued Watson Laboratories, subsidiary of Watson Pharmaceuticals, in connection with the submission of an abbreviated new drug application (ANDA) by Watson, seeking marketing approval from the US Food and Drug Administration (FDA) for dutasteride and tamsulosin hydrochloride capsules.
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Dutasteride and tamsulosin hydrochloride capsules of Watson Pharma are the generic version of GSK‘s JALYN, which is used to treat symptomatic benign prostatic hyperplasia (BPH) in men suffering from an enlarged prostate.
The lawsuit was filed in US District Court for the District of Delaware for preventing Watson from commercializing its product before the expiration of GSK’s US patent no. 5,565,467.