Daiichi Sankyo Files NDA in Japan for Marketing of the Methylene Blue Injection Medicinal Product
News Mar 25, 2014
Provepharm has announced that Daiichi Sankyo, Co. Ltd., a global pharmaceutical firm, has filed an NDA (New Drug Application) for the development and marketing of the injectable Methylene Blue medicinal product in Japan, made out of Provepharm’s Proveblue® Methylene Blue active substance.
In November 2011, Provepharm out-licensed to Daiichi Sankyo the exclusive rights for developing and marketing its medicinal product in Japan. It is already approved by the European Medicines Agency for the treatment of metheamoglobinaemia induced by medicinal and chemical products. It is traded in Europe as ’Methylthioninium chloride Proveblue 5mg/ml solution for injection’.
Methylene Blue is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs set up by the Ministry of Health, Labour and Welfare in Japan. Daiichi Sankyo is committed to making this drug available to Japanese patients waiting for it to be approved.