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news.GlaxoSmithKline (GSK) and Daiichi Sankyo have reached an agreement to co-promote GSK’s Rotarix - for use in infants to prevent gastroenteritis caused by rotavirus - in Japan.
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Clinical trials conducted in Japan and overseas have confirmed that Rotarix prevents severe rotavirus gastroenteritis and all rotavirus gastroenteritis.
The Ministry of Health, Labour and Welfare (MHLW) has granted GSK approval to sell Rotarix in Japan on 1 July 2011.
GSK also received approval for a significant new indication in Japan for Lamictal (lamotrigine) Tablets 25mg and 100mg for the prevention of depressive episodes in adult patients with bipolar disorder.
GSK Japan president Philippe Fauchet said in total, they have now received 24 new product approvals, including eight new chemical entities, since 2009.
"We are particularly pleased to contribute to preventative healthcare with the approval of our rotavirus vaccine and we hope this will help to reduce the significant burden of this disease in Japan," Fauchet said.
"In addition, with the new indication for lamotrigine, we now have the first approved treatment for bipolar disorder available in Japan to help prevent depressive episodes in adults with bipolar disorder."