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Alkermes Submits NDA in Japan


Posted on 2006-12-20 13:35:00



Biotech drug developer Alkermes Inc. said Wednesday that its partner submitted a new drug application to the Pharmaceuticals and Medical Devices Agency for marketing approval in Japan of an anti-psychotic medication for the treatment of schizophrenia.

Risperdal Consta has been approved by the U.S. Food and Drug Administration and now is approved in more than 70 countries worldwide. Alkermes said the Japanese organization of its partner Janssen-Cilag, Janssen Pharmaceutica K.K., submitted the application in that country.

Under the development and supply agreement between Janssen-Cilag and Alkermes, Risperdal Consta is manufactured by Alkermes, and Janssen-Cilag is responsible for worldwide sales and marketing. Alkermes receives manufacturing fees and royalties on product sales.