Daiichi Sankyo gets Japanese approval for Methylene Blue

5 January 2015

Japanese drug major Daiichi Sankyo (TYO: 4568) has received approval in Japan for the manufacture and marketing of the methemoglobinemia treatment, Methylene Blue Injection 50mg (methylthioninium chloride hydrate) for toxic methemoglobinemia.

Toxic methemoglobinemia is a toxic disorder in which the methemoglobin concentration in the blood is elevated due to various substances found in drugs, pesticides, etc., causing symptoms such as cyanosis, headache, dizziness, shortness of breath, and loss of consciousness.

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, Labor and Welfare (MHLW), to accelerate the development process for drugs not yet approved in Japan but which have been available in Europe and the USA.

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