Wednesday, May 28, 2008

New Eloxatin (oxaliplatin injection) Prescribing Information in the U.S. Includes Six-Year Overall Survival Data

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include six-year overall survival analysis from the MOSAIC trial in the Eloxatin(R) (oxaliplatin injection) prescribing information (PI). The new PI also reports five-year disease free survival (DFS) data in Stage III colon cancer patients treated following surgery to remove the primary tumor.

The whole story can be read here.

No comments: