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Home Industry News Otsuka receives approval for Samsca

Otsuka receives approval for Samsca

13th August 2009

Otsuka Pharmaceuticals has received approval from the European Commission for the marketing authorisation application it submitted regarding the distribution of its oral once-daily medication Samsca (tolvaptan), a selective V2-vasopressin receptor antagonist.

The organisation, which has its UK headquarters in Uxbridge, has received a licence for what will be Europe’s first-ever oral vasopressin antagonist for hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Dr Chris Thompson, professor of endocrinology at Beaumont Hospital, Dublin, welcomed the news that tolvaptan can be used in the treatment of hyponatraemia due to SIADH.

“Clinicians will be aware of the excellent safety record and efficacy of tolvaptan in published trial data and will welcome the availability of a therapeutic agent which specifically treats the underlying cause of hyponatraemia,” he added.

Last summer, Otsuka Pharmaceutical announced a capital investment to acquire Interpharma Praha – a business founded in 1932 focusing on active pharmaceutical ingredients and the development and manufacture of X-ray contrast media.

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