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Japan’s Ministry Approves Doxil For Ovarian Cancer

This article was originally published in PharmAsia News

Executive Summary

The Ministry of Health, Labor and Welfare Pharmaceutical Affairs Division March 30 approved Doxil (doxorubicin) for the additional indication of ovarian cancer in Japan. The approval came with a postmarket all-case surveillance condition as the Ministry cited lack of clinical data. Marketed in Japan by Janssen Pharmaceutical K.K, doxorubicin was previously approved for AIDS-related Kaposi's sarcoma in Japan. Japan's ovarian cancer patient groups petitioned the MHLW for the drug's approval. (Click here for more - Japanese language



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