FDA approves injection concentrate formulation for docetaxel

August 26, 2010

The FDA has approved a new one-vial formulation of the chemotherapeutic agent docetaxel (Taxotere Injection Concentrate).

The FDA has approved a new one-vial formulation of the chemotherapeutic agent docetaxel (Taxotere Injection Concentrate).

The agent is anticipated to become available nationwide in the fall in both 80-mg and 20-mg dosages.

Previously, docetaxel was available in a two-vial formulation-one vial containing docetaxel concentrate and the other with the diluent. The single vial eliminates the need for the initial dilution step with the diluent. Now at 20 mg/mL concentration, it is ready to be added directly into the infusion solution.

With one-vial docetaxel, the pharmaceutical ingredients and the 1-hour intravenous infusion administration to the patient remain the same.

Docetaxel is approved by the FDA for use in treating five types of cancer, including metastatic androgen-independent prostate cancer.