Sanofi-aventis announced that the FDA has approved a one-vial formulation of Taxotere (docetaxel injection concentrate). Taxotere was previously available as a two-vial formulation— one-vial containing docetaxel concentrate and the other with the diluent. The one-vial Taxotere eliminates the need for the initial dilution step with the diluent and is ready to be added directly into the infusion solution.

Taxotere is a chemotherapeutic agent indicated for use in treating patients at specific stages of five types of cancer: metastatic and adjuvant breast cancer, metastatic androgen independent prostate cancer, advanced non-small cell lung cancer, advanced gastric adenocarcinoma and locally advanced squamous cell carcinoma of the head and neck.

The one-vial formulation of Taxotere is expected to be available Fall 2010 in 20mg/mL and 80mg/mL dosage strengths. The two-vial formulation will continue to be available.

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