First Committee on Drugs of Japan?s Pharma Affairs reviews Novo Nordisk's Ryzodeg

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Novo Nordisk, a global healthcare company, announced that Ryzodeg (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan?s Pharmaceutical Affairs. The remaining step in the regulatory process is an approval from the Ministry of Health, Labour and Welfare.

The First Committee on Drugs of Pharmaceutical Affairs serves as an advisory body to the Ministry in matters related to pharmaceuticals including new drug applications. The passing of the review by the drug committee is an essential milestone in the Japanese review process prior to a marketing authorisation from the Ministry.

Novo Nordisk expects to receive marketing authorisation from the Ministry within a few months.

http://pharmabiz.com/NewsDetails.aspx?aid=72465&sid=2
 
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