FDA Approves Docetaxel Injection One-vial Formulation

The US Food and Drug Administration (FDA) has approved a new one-vial formulation of docetaxel injection concentrate (Taxotere, sanofi-aventis). This new formulation eliminates the initial dilution step, as well as the second vial containing the diluent. With the one-vial formulation, the pharmaceutical ingredients and the 1-hour intravenous infusion administration remain unchanged.

 

Docetaxel is approved for use in treating patients at specific stages of: 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.