The Second Sub-Committe on Drugs of Japan's Council on Drugs and Food Sanitation (CDFS) has recommended the following approvals: US drugmaker Schering-Plough's Temodar (temozolomide), for malignant brain tumor; domestic firm Kirin Brewery's Busulfe IV (busulfan), a pretreatment for allogeneic hematopoietic stem cell transplantation; and USA-based Baxter's Feiba (anti-inhibitor coagulant complex) for hemophilia.
The committee's decisions will be forwarded to the Subcommittee on Drugs for formal clearance. Janssen-Cilag's doxorubicin, for Kaposi's sarcoma associated with AIDS, was granted orphan status at the meeting.
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